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1、2022 Biosimilars Report:The U.S.Journey and Path Ahead23Welcome to our 2022 Biosimilars Report:The U.S.Journey and Path AheadCardinal Health is fortunate to sit at the crossroads of the United States(U.S.)healthcare system,engaging with stakeholders from across the industry including healthcare prov

2、iders,health systems,pharmaceutical and medical product manufacturers,pharmacists,payers and policy makers to support the delivery of essential care to the most important stakeholder patients.This vantage point has given us a unique perspective on the important role of biosimilars in the U.S.healthc

3、are landscape and the potential benefits they may deliver to patients and the healthcare system at large.Since the first biosimilar was approved in the U.S.in 2015,we have taken an active role in supporting the use of these products not only by distributing them to healthcare providers and working w

4、ith manufacturers to bring new biosimilars to market,but also through extensive research and educational initiatives designed to build a better understanding of how biosimilars may contribute to high-quality,lower-cost care.In this,our first-ever Biosimilars Report:The U.S.Journey and Path Ahead,we

5、have aspired to bring together the latest industry data on utilization and payer coverage with our own research and perspectives from leading experts on where biosimilar adoption stands today in the U.S.,and what we can expect in 2022 and beyond.We are pleased to include views from our internal expe

6、rts and top physicians in key therapeutic areas where biosimilars are making an impact.The report also features results from our research with healthcare providers,which includes surveys with more than 320 oncologists,100 rheumatologists,100 retina specialists,50 endocrinologists and primary care ph

7、ysicians treating diabetes,and 115 pharmacists.The future of biosimilars in the U.S.is exciting not only because of their potential to lower the costs of biologic medicines and to make care more accessible to patients,but also because they will create space for new innovations and scientific breakth

8、roughs.As we move forward in 2022,enabling new advancements in care and better access for patients are goals that all healthcare stakeholders should be aligned on.We look forward to collaborating with our customers,partners and industry colleagues on these efforts.Wishing you good health in 2022!Sin

9、cerely,Victor Crawford CEO,Pharmaceutical Segment Cardinal HealthINTRODUCTIONTable of contents Biosimilars 101 2021 Biosimilars Landscape FDA Approved Biosimilars Overall U.S.Biosimilars Market Share Biosimilars Adoption Rates Provider Trends Oncology Rheumatology Ophthalmology Diabetes Payer Trends

10、 Five Biosimilars Predictions for 202245A Biosimilars Primer:Medications That Drive Competition,Lower Costs and Increase Accessibility Biosimilar treatment options are proven to be just as safe and effective as originator biologics.Biosimilars are approved through an abbreviated FDA pathway,with the

11、 goal of expanding patient access to high-quality,lower-cost care.As of January 2022,there are 33 FDA approved biosimilars in the U.S.,21 of which are commercially available on the market.BIOSIMILARS 101Although the first biosimilar was approved by the U.S.Food and Drug Administration(FDA)nearly sev

12、en years ago,this class of products is still new to many who work in healthcare,particularly in therapeutic categories such as diabetes and ophthalmology where biosimilars have received approval only recently.The following is a primer of the key terms and facts related to biosimilars.What is a biosi

13、milar and how does it compare to a generic?A biosimilar is a biologic treatment(i.e.,made from living cells)that is just as safe and effective as an existing FDA-approved biologic,also referred to as the“reference product.”Unlike generics,which are manufactured from small-molecule,chemical compounds

14、 and have the same active ingredients as brand name drugs,biologics are large,complex molecules that are manufactured from living cells,which results in inherent variability associated with them.Therefore,where a generic must demonstrate bioequivalence to the brand drug,biosimilars must demonstrate

15、they are highly similar to the reference product thus the term“biosimilar.”In the U.S.,biosimilars are currently used to treat patients with cancers,kidney diseases,diabetes,and other autoimmune diseases such as rheumatoid arthritis and Crohns disease.How are biosimilars reviewed and approved by the

16、 FDA?Biosimilar advancements in the U.S.began when the Biologics Price Competition and Innovation Act was enacted in 2010,which established an abbreviated pathway to FDA approval for biosimilars under section 351K,with the aim of enabling greater patient access to lower-cost,high-quality products.Th

17、e approval process requires biosimilar manufacturers to submit data that demonstrates there is no clinically meaningful difference from the reference biologic.Although the approval pathway for biosimilars is abbreviated,the FDA requires biosimilars to meet equally rigorous approval standards,which m

18、eans patients and healthcare professionals can be assured of their safety,efficacy and quality just as they would the reference products.Industry analysts say that biosimilars are on track to reduce U.S.drug expenditure by$133 billion by 2025.67How many biosimilars are on the market in the U.S.?As o

19、f January 2022,there are 33 FDA-approved biosimilars,21 of which are available on the U.S.market.Ten of the 33 products have delayed launches primarily due to patent litigation between the reference biologic and biosimilars companies.Of the 21 biosimilars on the market,17 are used for treatments ass

20、ociated with cancers,three are used to treat autoimmune conditions and one is used to treat diabetes(See Figure 1 for full details).What does“interchangeability”mean and why is it important?Interchangeability is a regulatory designation for biosimilars that is unique to the U.S.The designation allow

21、s“pharmacist-level substitution,”meaning that a pharmacist can substitute the reference biologic with a biosimilar per state laws,without consulting with the prescribing physician.This is similar to how pharmacists routinely substitute generic drugs for brand name drugs today.For biosimilars dispens

22、ed at the retail pharmacy and/or covered under the patients pharmacy benefit(such as insulin and Humira biosimilars),the interchangeability designation is important because it will enable pharmacists to help facilitate patient access to high-quality treatment options at the lowest cost.A common misc

23、onception is that interchangeable biosimilars must meet higher standards for approval than non-interchangeable biosimilars.However,all biosimilars whether interchangeable or not undergo rigorous and thorough evaluations to ensure safety and effectiveness in order to meet the FDAs high standards for

24、approval.Interchangeability designation is obtained through the submission of additional data,generally in the form of switching studies,to assess the safety of switching between a reference product and biosimilar multiple times.Why are biosimilars important to the U.S.healthcare system?Biologics ar

25、e among the most expensive medicines in the U.S.some with costs totaling tens of thousands of dollars each year per patient.Biosimilars are expected to be priced 15%to 30%lower than their reference products.1 The market entrance of biosimilars leads to greater competition,thereby lowering costs and

26、increasing accessibility and affordability of these critical treatments.Industry analysts say that biosimilars are on track to reduce U.S.drug expenditure by$133 billion by 2025.2The U.S.is already seeing how biosimilars are reducing costs:In 2020 alone,biosimilars saved$7.9 billion(more than triple

27、 the$2.5 billion saved the previous year),with savings expected to grow significantly in the next few years as more biosimilars enter the market.3If biosimilars are more affordable,why are they not more widely used?The U.S.healthcare market is complex,particularly the payer dynamics that dictate how

28、 drugs are reimbursed.Although biosimilars are generally priced lower,stakeholder incentives are not always aligned to enable or support biosimilar adoption.In addition to the“Biosimilars whether interchangeable or not undergo rigorous and thorough evaluations to ensure safety and effectiveness in o

29、rder to meet the FDAs high standards for approval.BIOSIMILARS 101BIOSIMILARS 101financial considerations,continued knowledge gaps among some key stakeholders(including providers and patients)regarding biosimilars can be a barrier to adoption.The lack of familiarity with biosimilars contributes to he

30、sitancies with these products and is a key driver behind recent congressional and FDA activities,including the passage of the Advancing Education on Biosimilars Act of 2021,intended to increase education and awareness among providers.What resources are available to provide further information on bio

31、similars?Those who wish to learn more about biosimilars can explore the FDAs Biosimilars website,which includes a wealth of educational material,and the“Purple Book,”which is the official database for all FDA-licensed biological products including reference biologics,biosimilars and interchangeable

32、biosimilars.In addition,Cardinal Health has educational resources,thought leadership and a full listing of available biosimilars,as well as an interactive tool that can be used to look up state laws related to interchangeability.892021 Biosimilars Landscape2021 BIOSIMILARS LANDSCAPE2021:A Year of Mi

33、lestones and Progress for Biosimilars in the U.S.To begin a reflection of 2021 biosimilars activity,I cannot help but to think back to when I first began working in biosimilars and U.S.national strategies over five years ago.My passion for this space grew quickly as I saw how healthcare organization

34、s,and more importantly patients,continued to grapple with the rising healthcare costs associated with critical biologics.Fast forward to today,and I am deeply encouraged by the progress made in the U.S.,especially this past year.Following the launch of the first biosimilar in 2015,we now have 33 FDA

35、 approved biosimilars with 21 available on the market as of January 2022.The U.S.biosimilars story that was initially described as sluggish and delayed has now transformed to one of progress and momentum.This past year,the promise of biosimilars has started to become a reality,as greater competition

36、 for some of the costliest biologic treatments on the market is beginning to drive meaningful cost savings.The promise of biosimilars has started to become a reality,as greater competition.is beginning to drive meaningful cost savings.“By promoting negotiation,competition and innovation in the healt

37、hcare industry,we will ensure cost fairness and protect access to care.”-U.S.Department of Health and Human Services Secretary Xavier Becerra4Sonia T.Oskouei,PharmDVice President,Biosimilars Cardinal Health1011Increasing competition through the introduction of biosimilars creates opportunity to decr

38、ease the financial burden associated with these products,which in turn could reduce the risk for negative outcomes due to medication nonadherence.Significant progress has been made in the adoption of biosimilars in the U.S.,particularly in oncology,where all three classes of therapeutic oncology bio

39、similars(i.e.,rituximab,bevacizumab,and trastuzumab)have exceeded 60%market share(See Figure 2).Savings from biosimilars increased to approximately$8 billion in 2020 alone,more than tripling savings derived from previous years.In addition,for the first time in seven years,oncology expenditure growth

40、 fell below 10%due to the impact of biosimilars and new product launches.5Although 2021 brought fewer market entrants than previous years,it was still one of the most eventful years in U.S.biosimilars history.Several key milestones were achieved this past year,and the following represent just a few

41、worth highlighting:The first interchangeable biosimilar was approved in the U.S.In July 2021,the FDA made a landmark decision to approve the first interchangeable biosimilar in the U.S.for Viatris Semglee(insulin glargine-yfgn),referencing the long-acting insulin,Lantus.The approval was significant

42、for a multitude of reasons:Not only is Semglee the first interchangeable biosimilar,but the first biosimilar in diabetes care,and the first biosimilar that is primarily dispensed at retail pharmacies;therefore,its billed under the pharmacy benefit.2021 BIOSIMILARS LANDSCAPE2021 BIOSIMILARS LANDSCAPE

43、Figure 1.FDA approved biosimilarsBiosimilars to be launched;all others are currently marketed.Biologics that are not true biosimilars and were approved under either the 351(a)or 505(b)(2)pathways.Reference Product(molecule)CompanyBiosimilar Product(s)Biosimilar Company(Estimated)Launch DateAvastin (

44、bevacizumab)GenentechMvasiAmgenJuly 2019ZirabevPfizerJan.2020Epogen/Procrit (epoetin alfa)Amgen/JanssenRetacritPfizerNov.2018Enbrel (etanercept)AmgenEticovoSamsung2029ErelziSandoz2029Herceptin (trastuzumab)GenentechKanjintiAmgenJuly 2019OgriviViatrisDec.2019TrazimeraPfizerFeb.2020HerzumaTevaMar.2020

45、OntruzantOrganonMay 2020Humira (adalimumab)AbbVieAmjevitaAmgenJan.2023HadlimaOrganonJune 2023Cyltezo*Boehringer IngelheimJuly 2023YusimryCoherusJuly 2023HulioViatrisJuly 2023HyrimozSandozSept.2023AbriladaPfizerNov.2023Reference Product(molecule)CompanyBiosimilar Product(s)Biosimilar Company(Estimate

46、d)Launch DateLucentis(ranibizumab)GenentechByoovizBiogenJune 2022Lantus (insulin glargine)SanofiBasaglarEli LillyDec.2016Semglee*ViatrisAug.2020RezvoglarEli LillyTBDNeulasta (pegfilgrastim)AmgenFulphilaViatrisJuly 2018UdenycaCoherusJan.2019ZiextenzoSandozDec.2019NyvepriaPfizerDec.2020Neupogen (filgr

47、astim)AmgenNivestymPfizerOct.2018GranixTevaNov.2013ZarxioSandozSept.2015Remicade (infliximab)Janssen*InflectraPfizerNov.2016RenflexisOrganonJuly 2017AvsolaAmgenJuly 2020Rituxan (rituximab)GenentechTruximaTevaNov.2019RuxiencePfizerFeb.2020RiabniAmgenJan.2021Source:U.S.Food&Drug Administration.Retriev

48、ed from:https:/www.fda.gov/drugs/biosimilars/biosimilar-product-information.*Semglee gained FDA approval as an interchangeable biosimilar on July 28,2021,and Cyltezo gained an interchangeability designation in October 2021.*Ixifi(Pfizers other Remicade biosimilar)has no plans to launch in the U.S.12

49、13Figure 2.Overall U.S.biosimilars market shareProductCategory1st Biosimilar LaunchCurrent Number of Biosimilar CompetitorsBiosimilar Market Share(Sept.2021)Neupogen(filgrastim)Supportive Care2015 2*89%Remicade(infliximab)Immunology2016332%Epogen/Procrit(epoetin alfa)Supportive Care2018152%Neulasta(

50、pegfilgrastim)Supportive Care2018438%*Avastin(bevacizumab)Oncology2019274%Herceptin(trastuzumab)Oncology2019560%Rituxan(rituximab)Oncology2019364%Lantus(insulin glargine)Diabetes2020*1*3%8 Product Classes21*Excludes Granix.*Neulasta Syr.only biosimilars market share is 75%.*Excludes Basaglar.Include

51、s Semglee,which transitioned to an interchangeable biosimilar in July 2021.This approval has significant opportunity to expand lifesaving treatment options for the millions of insulin-dependent Americans living with diabetes.Despite its discovery a century ago,insulin continues to be among the costl

52、iest treatments for patients with diabetes,with studies showing nearly one in four patients ration insulin.6 Between 2001 and 2018,the average list price of insulin products has increased around 11%annually.7Increasing competition through the introduction of biosimilars creates opportunity to decrea

53、se the financial burden associated with these products,which in turn could reduce the risk for negative outcomes due to medication nonadherence.Furthermore,the introduction of an interchangeable insulin biosimilar may draw heightened attention to the healthcare delivery system and reimbursement mode

54、l for pharmacy benefit products,fueling additional policy reform discussions.Additionally,the entrance of interchangeable biosimilars into the retail pharmacy class of trade will empower retail pharmacists,some of the most trusted and accessible healthcare providers,to play a key role in influencing

55、 biosimilar adoption(with the ability to automatically substitute interchangeable products,per state laws)and to champion the education process in their communities.The first biosimilar for ophthalmology was approved in the U.S.In September,the FDA approved Biogens Byooviz(ranibizumab-nuna),the firs

56、t ophthalmology biosimilar for Lucentis(ranibizumab)to treat retinal conditions including neovascular(wet)age-related macular degeneration(AMD).This noteworthy approval is anticipated to expand treatment options with lower-cost,high-quality therapies for the approximately 11 million Americans diagno

57、sed with AMD.8 As Byooviz prepares to launch this year,retina specialists and ophthalmologists will have more treatment options than ever before to try to tackle the economic and treatment 2021 BIOSIMILARS LANDSCAPE2021 BIOSIMILARS LANDSCAPEburdens associated with retinal conditions.However,findings

58、 from early market research with U.S.retina specialists indicate a lack of familiarity and comfort with biosimilars,which suggests a critical need for targeted educational efforts to help alleviate potential hesitancies and close knowledge gaps early on.9The first Humira(adalimumab)biosimilar achiev

59、ed interchangeability designation,representing the second interchangeable biosimilar approved in the U.S.In October 2021,Boehringer Ingelheims Cyltezo(adalimumab-adbm)was granted interchangeability status,a long-awaited accomplishment for the biosimilar that was first approved in 2017.Cyltezo is cur

60、rently one of seven FDA approved adalimumab biosimilars that are lined up to hit the market in 2023.With multiple other candidates in development,and various product attributes associated with each one,competition is expected to be fierce.(Visit here for a more detailed Humira biosimilar landscape o

61、verview).Although Cyltezo is the first adalimumab biosimilar to achieve interchangeability status,it is not expected to be the last.Alvotech/Teva,Pfizer,Amgen and Organon/Samsung Bioepis have all revealed that they are pursuing interchangeability designation for their adalimumab candidates as well.I

62、t is no coincidence that the number one selling drug in the world,Humira,comes with the most extensive list of biosimilar candidates.With wide use in the management of autoimmune conditions including rheumatoid arthritis,psoriasis and Crohns disease,the market entrance of adalimumab biosimilars will

63、 serve as one of the most significant events to impact U.S.healthcare costs in recent history.Source:IQVIA:Accessed via IQVIA National Sales Perspective(NSP)SMART Data.(October 2021).1415Source:IQVIA:Accessed via IQVIA National Sales Perspective(NSP)SMART Data.(October 2021).*Filgrastim excludes Gra

64、nix.*Neulasta Syr.only biosimilars market share is 75%*Insulin glargine excludes Basaglar.2021 BIOSIMILARS LANDSCAPERegulatory activities drew heightened attention to biosimilarsAs the U.S.continued to struggle with challenges related to the COVID-19 pandemic,congressional and government discussions

65、 around drug pricing and affordable care remained a top priority in 2021.In April,President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices and addressing some key barriers to biosimilar adoption:The Advancing Education on Biosimilars Act and The Ensuring Innova

66、tion Act.10 The former is intended to lower healthcare costs by strengthening provider and patient confidence in biosimilars through enhanced educational efforts,thereby increasing utilization,enabling greater competition in the market and lowering costs to the overall healthcare system.The latter i

67、s intended to limit the circumstances in which additional market exclusivity is granted to a reference product,ensuring any modification represents true innovation.The goal is to close potential loopholes that can delay competition and accessibility to lower-cost treatment alternatives,including bio

68、similars.Additionally,in response to President Bidens Executive Order,the Department of Health and Human Services(HHS)released a comprehensive plan for addressing high drug prices this past September.The 29-page report,which outlines key principles for drug pricing reform through competition,innovat

69、ion and transparency,mentions“biosimilars”over 90 times and“interchangeability”25 times.112021 BIOSIMILARS LANDSCAPESavings from biosimilars increased to approximately$8 billion in 2020 alone,more than tripling savings derived from previous years.Rituxan(rituximab)Herceptin(trastuzumab)Avastin(bevac

70、izumab)Neupogen(filgrastim)*Epogen/Procrit(epoetin alfa)Remicade(infliximab)Neulasta(pegfilgrastim)*Lantus(insulin glargine)*Figure 3.Use of biosimilars has grown significantly since 2015.03Jan-16Jul-16Jan-17Jan-18Jan-19Jan-20Jan-21Jul-17Jul-18Jul-19Jul-20Jul-21Jan-2210203032403850526060706480749089

71、Total Biosimilar Share(%)1617Months since first biosimilar launched05102030405015253545556065702021 BIOSIMILARS LANDSCAPE2021 BIOSIMILARS LANDSCAPE0102030405060708090While these noteworthy events signal that the tide is starting to turn toward greater biosimilar adoption,this past year also proved t

72、hat significant barriers and challenges still exist.Although there has been stronger use of biosimilars in oncology(17 of the 21 biosimilars on the market have oncology indications),progress in other areas such as rheumatology has continued to be slow.On the payer front,the landscape continues to be

73、 complex,with formulary decisions that have challenged the uptake and management of biosimilars and policies varying across plans.And as market research continues to indicate,clinical barriers and knowledge gaps remain in the market,with increased desire for data and evidence around switching betwee

74、n reference biologics and biosimilars,as well as between biosimilars.Collaboration among all healthcare stakeholders will be needed to overcome many of these barriers and to ensure a viable biosimilars market in the U.S.Our 2022 Biosimilars Report will take a deeper examination of many of these issu

75、es and what steps the industry will need to take to ensure patients have access to these high-quality,lower-cost treatment options.Although there has been stronger use of biosimilars in oncology,progress in other specialty areas such as rheumatology has continued to be slow.Source:IQVIA:Accessed via

76、 IQVIA National Sales Perspective(NSP)SMART Data.(October 2021).*Filgrastim excludes Granix.*Neulasta Syr.only biosimilars market share is 75%.*Insulin glargine excludes Basaglar.Figure 4.Adoption of biosimilars typically accelerates quickly after market introduction.Rituxan(rituximab)Herceptin(tras

77、tuzumab)Avastin(bevacizumab)Neupogen(filgrastim)*Epogen/Procrit(epoetin alfa)Remicade(infliximab)Neulasta(pegfilgrastim)*Lantus(insulin glargine)*Total Biosimilar Share(%)1819PROVIDER TRENDSProvider TrendsThe success of biosimilars in the U.S.is dependent on many different stakeholders,but the healt

78、hcare provider remains central to every treatment decision.As data from Europe and the U.S.over the past 15 years has demonstrated,when providers gain clinical confidence with biosimilars,adoption increases exponentially.12With this knowledge in mind,Cardinal Health began conducting research about b

79、iosimilars with oncologists starting in 2015 to assess their familiarity and understanding of biosimilars,and to identify concerns and barriers that might impede adoption.Over the years,as new biosimilars have received FDA approval,we have expanded our provider research to include rheumatologists an

80、d ophthalmologists.Most recently,we broadened our provider surveys into diabetes care and included both prescribers(endocrinologists and primary care physicians)and pharmacists,who are now empowered to make decisions about substituting insulin biosimilars for reference biologics at the time of dispe

81、nsing.Our research has provided valuable perspective into the views of each provider group,enabling us to better understand their similarities and differences.The next section of this report highlights key findings from our most recent healthcare provider surveys(conducted in 2020 2021),along with i

82、nsights from leading physicians in each therapeutic area.Oncology (Prescribers)N=323Rheumatology (Prescribers)N=102Ophthalmology (Prescribers)N=102Diabetes (Prescribers)N=54Figure 6.For which patients are you most likely to prescribe a biosimilar?(Select all that apply.)(Surveys conducted 2020-2021)

83、Very familiarSomewhat familiarNot very familiarNew patientsExisting patients having success on a reference productExisting patients having limited success on a reference product Existing patients for whom payers have mandated a biosimilar Note:This answer choice was not included in oncology and opht

84、halmology surveys.I am not likely to prescribe a biosimilar for any patient at this time67%32%42%19%67%5%42%N/A11%35%30%72%27%38%25%5%7%Figure 5.How would you describe your familiarity with biosimilars?(Surveys conducted 2020-2021)55%40%53%63%39%48%45%33%6%12%2%4%20%2%The majority of participating p

85、hysicians are familiar with biosimilars,but prescribing patterns vary by specialty.N/A2021Oncologists are comfortable with biosimilars,but changes in value-based care may impact utilizationBruce Feinberg,DOVice President/Chief Medical Officer for Cardinal Health Specialty SolutionsThe approval of th

86、e first biosimilar in the U.S.,Zarxio(filgastrim-sndz),in March 2015 represented a sea change in the biologic drug marketplace with broad impact for all stakeholders.Recognizing this new class of medicine would bring significant change to oncology care,our team at Cardinal Health began conducting re

87、search with oncologists in 2015 to gauge their understanding and desire to use biosimilars,and we have maintained these studies over the past seven years.Over the course of this time,we have measured how physician views and utilization rates have changed and tracked the relationship between utilizat

88、ion and payer benefit design.One of our early conclusions about biosimilar adoption,as cited in our 2018 JAMA Oncology publication,was that the rate and depth of biosimilar adoption was more likely to depend on payer programs and value-based care models than on the inclusion of biosimilars in clinic

89、al guidelines.13 This conclusion proved prescient.Value-based care(VBC)initiatives like the Oncology Care Model(OCM),in which physicians assume greater financial risk for administered healthcare,have been shown to have the most effective influence on driving biosimilar adoption by oncologists in an

90、unrestricted oncology marketplace.14 Conversely,commercial payers and pharmacy benefit managers(PBMs)initially impeded biosimilar adoption in oncology in the early years of biosimilar availability,but as coverage has improved in recent years,market uptake of oncology biosimilars has similarly increa

91、sed(as shown in Figure 3).Provider perceptions of biosimilars over this time period have evolved from a 22%acceptance of interchangeability in 2017 to a near 100%for some indications in 2021.In this same time period,oncologists have grown comfortable using biosimilars in all clinical categories in o

92、ncology:supportive care,palliative care and curative intent and a strong majority are comfortable with non-medical switching.Despite oncologists positive perceptions of biosimilars,uncertainty for oncology biosimilars lies ahead due to the changing value-based care landscape.The OCM will expire in 2

93、022,and with no replacement VBC reimbursement model yet announced,oncology practices may see a gap for as long as 18 months,which could result in prescribing patterns reverting to prior brand preferences.Oncology biosimilars may also face greater competition from the improved efficacy of second and

94、third generation iterations of reference therapies that are rapidly entering the market,as well as innovative new targeted therapies,which are continuing to change the oncology treatment landscape.In spite of these uncertainties about the future,in the near term,we anticipate oncologists will contin

95、ue to adopt biosimilars and their experiences may serve as a model for other therapeutic areas where biosimilars will launch in 2022,such as vascular endothelial growth factor(VEGF)inhibitors for retinal diseases.ONCOLOGY TRENDSONCOLOGY TRENDSFigure 7.Would you prescribe a biosimilar in indications

96、that have been granted FDA approval based on extrapolation?(Surveys conducted in 2020-2021)N=323Figure 8.What is your comfort level with automatic substitution of a biosimilar for its reference product by a pharmacy or an insurance company?(Surveys conducted in 2020-2021)N=323Yes.85%7%3%5%0%Yes,but

97、only for biosimilars that provide supportive care.Yes,but only for biosimilars that provide curative treatment.No,I would not prescribe biosimilars without clinical data to demonstrate their safety and efficacy for a specific indication.I would not prescribe a biosimilar.36%16%39%7%1%Very comfortabl

98、eModerately comfortableSomewhat comfortableNot very comfortableNot at all comfortableMore than nine in 10 participating oncologists are comfortable prescribing a biosimilar with an FDA approval based on extrapolation.More than seven in 10 participating oncologists said they are very or moderately co

99、mfortable with automatic substitution of biosimilars.Only 5%of participating oncologists said they would not prescribe biosimilars for indications without clinical trial data.2223ONCOLOGY TRENDSFigure 11.Which therapeutic biosimilars have you prescribed in the past year?(Select all that apply.)(Surv

100、eys conducted in 2020-2021)N=323Herceptin(trastuzumab)Avastin(bevacizumab)Rituxan(rituximab)Other,please specifyNone of the above68%62%67%11%8%The majority of oncologists have prescribed biosimilars to Avastin,Herceptin and Rituxan in the past year.Figure 10.Which of the following best aligns with y

101、our perspective on switching from one biosimilar to another biosimilar?(Surveys conducted in 2020-2021)N=323I feel comfortable with the science behind biosimilars and therefore feel comfortable switching between biosimilars.73%20%6%1%I only feel comfortable switching between biosimilars if they are

102、for supportive(i.e.,filgrastim and pegfilgrastim)care.I do not feel comfortable switching between biosimilars.I will not prescribe a biosimilar to any of my patients.More than 90%of participating oncologists said they are comfortable switching between biosimilars in at least some cases.Oncologists s

103、ay they feel comfortable switching patients to biosimilars for both curative and palliative intent.Figure 9.Which of the following best aligns with your perspective on biosimilars administered for curative intent?(Surveys conducted in 2020-2021)N=323I only feel comfortable starting new patients on b

104、iosimilars with the intent to cure.I feel comfortable switching patients from a reference biologic to a biosimilar with the intent to cure.I will not prescribe biosimilars with curative intent to any of my patients.Figure 9-1.Which of the following best aligns with your perspective on biosimilars ad

105、ministered for palliative intent?(Surveys conducted in 2020-2021)N=32325%67%8%I only feel comfortable starting new patients on biosimilars for palliative intent.I feel comfortable switching patients from a reference biologic to a biosimilar for palliative intent.I will not prescribe biosimilars for

106、palliative intent to any of my patients.16%83%1%2425RHEUMATOLOGY TRENDSRHEUMATOLOGY TRENDSFigure 13.What is your top concern about prescribing biosimilars?(Surveys conducted in 2020)N=102Concerns about efficacy of biosimilars38%21%21%13%4%3%Evaluating when to prescribe a biosimilar versus a referenc

107、e productConcerns about lack of economic benefitLack of payer adoptionConcerns about manufacturingProviding patient educationFigure 12.How comfortable do you feel prescribing biosimilars to your patients?(Surveys conducted in 2020)N=102Not comfortableSomewhat comfortableVery comfortable41%49%10%The

108、promise of biosimilars remains unfulfilled in rheumatologyGordon Lam,MDMedical Director of Clinical Research at Arthritis&Osteoporosis Consultants of the CarolinasIn early 2020,Cardinal Health surveyed more than 100 rheumatologists to understand their attitudes about biosimilars.The findings showed

109、that despite an overwhelming familiarity(98%were somewhat or very familiar)and comfort level with biosimilars(88%expressed comfort with the FDA approval process,and 90%were comfortable with prescribing biosimilars),the majority were reluctant to use biosimilar products.Sixty-five percent of responde

110、nts felt that the economic climate was unfavorable to switch to biosimilars,and less than half said they were likely to prescribe a biosimilar to a new patient.This reluctance was based on a variety of concerns including skepticism of their efficacy and lack of meaningful cost savings to patients an

111、d practices.These concerns are not surprising considering that real-world evidence(RWE)of the cost-effectiveness of biosimilars in the U.S.has been scant,and presently,the most heavily used rheumatology biosimilars are priced at only 20%-35%below the reference products list price.15 In addition,many

112、 providers fear that the majority of the economic benefit will go to PBMs and payers,not to patients and practices.Lack of payer adoption was also cited as a key concern,with 66%of physicians stating they are unlikely to switch their patients from reference products to biosimilars until there is gre

113、ater adoption among payers.Paradoxically,uncertainty and lack of payer adoption may limit utilization and hence impede accumulation of RWE,but RWE is often needed to alleviate uncertainty and increase payer adoption.However,since the survey was conducted,there are signs that the landscape is beginni

114、ng to shift.Concerted efforts at physician and patient education have reduced skepticism about the efficacy and safety of these agents.Legislation has been proposed to increase transparency of biologic patents,which may curb litigation that delays entry of biosimilar competitors once theyre approved

115、.Regulations that target anti-competitive practices of exclusionary contracts may free the forces of supply and demand,thereby increasing access and lowering costs.Also,despite the sluggish sales of biosimilars to date,the net price of some reference products has fallen over the past few years,impac

116、ting the cost of healthcare in a different way.For example,the sale price of Janssens Remicade has fallen by an average of 19%annually since January 2018.16 The market share of rheumatology biosimilars is also growing slowly but steadily to 32%.17While slower than expected,the needle is gradually st

117、arting to move.It will take time to overcome these obstacles,but as it does,the value of biosimilars may be appreciated beyond that of mere price reduction.In doing so,utilization will increase,and the promise of biosimilars may be fulfilled.Four out of 10 rheumatologists felt very comfortable presc

118、ribing biosimilars,but efficacy remains the primary concern.More than 60%of rheumatologistssay they are unlikely to switch patients to biosimilars until there is greater payer adoption.2627Figure 15.When considering biosimilars as a treatment option,the importance of favorable economics for my pract

119、ice is:(Surveys conducted in 2020)N=102Figure 17.To what extent do you agree with the following statement?I am unlikely to switch my patients from reference products to biosimilars until there is a greater adoption of biosimilars among payers.(Surveys conducted in 2020)N=102RHEUMATOLOGY TRENDSRHEUMA

120、TOLOGY TRENDS24%23%22%23%29%42%14%9%11%3%Strongly agreeExtremely importantAgreeVery importantNeither agree or disagreeModerately importantDisagreeSlightly importantStrongly disagreeNot at all importantFigure 16.To what extent do you agree with the following statement?Today,the economics of biosimila

121、rs are not favorable enough to motivate me to switch from the reference products.(Surveys conducted in 2020)N=10228%18%27%27%36%47%7%6%2%2%Extremely importantStrongly agreeVery importantAgreeModerately importantNeither agree or disagreeSlightly importantDisagreeNot at all importantStrongly disagreeF

122、igure 14.When considering biosimilars as a treatment option,the importance of cost saving for my patients is:(Surveys conducted in 2020)N=102Most rheumatologists view cost savings to their patients as very important.About two-thirds of participating rheumatologists said the economics of biosimilars

123、are a barrier to adopting biosimilars.Nearly seven in 10 rheumatologists said cost savings for patients is extremely or very important.2829OPHTHALMOLOGY TRENDSOPHTHALMOLOGY TRENDSFigure 18.Which of these statements best reflects your understanding of clinical trial design in biosimilar development?(

124、Surveys conducted in 2020-2021)N=93Clinical trials conducted on biosimilars are adequate given the totality of evidence required for regulatory approval.Clinical trials conducted on biosimilars are not large enough in size in order to adequately investigate efficacy and safety.I have very limited kn

125、owledge of clinical trial design for biosimilars.39%27%34%Participating retina specialists were mixed in their understanding of clinical trial design for biosimilars.61%of retina specialists reported that they were aware of ophthalmic biosimilars in development.Adoption of biosimilars among retina s

126、pecialists will depend on education,price and payer influenceNancy M.Holekamp,MDDirector of Retina Services at the Pepose Vision InstituteWith the first ophthalmology biosimilar expected to launch in 2022,Cardinal Health saw an opportunity to survey ophthalmologists to better understand how prepared

127、 they feel to use this new class of medicines.The results of the survey confirm that biosimilars are an emerging treatment option for retina specialists in the U.S.Of the more than 100 respondents in the survey,only a minority(40%)agreed with the statement,“I am very familiar with biosimilars.I unde

128、rstand how the FDA defines and evaluates biosimilars.”That means the majority of retina specialists surveyed are not adequately familiar with biosimilars.In fact,when queried,82%of respondents requested additional educational information about the safety,efficacy and performance of biosimilars.If we

129、 consider this survey to be representative of retina specialists in general,there is an identifiable gap in knowledge surrounding biosimilars.This is the first important teaching point of the survey.To drive this point further,34%of retina specialists surveyed admitted very limited knowledge of clin

130、ical trial design for biosimilars.Additionally,46%of respondents cited,“I have little knowledge on the FDA approval pathway for biologics.”When it comes to the concept of extrapolation,only a small minority(18%)of those surveyed said they were fully aware of extrapolation and had no concerns about i

131、t,and nearly half(46%)of those surveyed stated they would not prescribe a biosimilar for indications that have been granted approval based on extrapolation.Thus,there is a suggestion that current impressions and answers in this survey are based on limited understanding and could possibly change over

132、 time with additional information and education.As biosimilars are introduced into the field of retina,the existence of an inexpensive,off-label treatment option,bevacizumab,which has been comfortably utilized by 100%of respondents in this survey,looms large.Further,97%do not have safety concerns,or

133、 believe the cost-effectiveness outweighs any concerns,with off-label compounded bevacizumab use.These two statistics represent the highest degree of agreement for any question in the survey.While 80%of retina specialists surveyed agree that ranibizumab/aflibercept biosimilars could reduce the use o

134、f off-label bevacizumab“if price discounts are significant enough,”in reality,achieving meaningful price discounts might be a tall order.In a related question,more than one third(37%)of those surveyed said a greater than 40%discount from the reference product would be necessary to prescribe a biosim

135、ilar.Yet today,bevacizumab can be purchased from compounding pharmacies for as little as$20 per syringe in most U.S.markets,meaning biosimilars may be hard pressed to compete on price.18The final teaching point from this survey regarding biosimilar use is the growing realization among retina special

136、ists that choice in prescribing behavior may no longer be only in the hands of the doctor.When asked,“Who ultimately has the greatest influence on which anti-VEGF biologics/biosimilars are utilized in your practice?”nearly half(48%)answered the prescriber,but close behind,40%of respondents answered

137、the payer.Then,when asked,“To what extent are you able to influence payer formularies and therefore treatment strategies for patients?”76%of retina specialists replied,“I have little influence or no influence on payer formulary decisions.”This may be the biggest battle facing physicians across all p

138、harmacologic therapeutic areas.There are forces larger than retina specialists at play that may alter the prescribing landscape,and as biosimilars continue to emerge,I believe the results of surveys such as this one will evolve and over time change dramatically.3031OPHTHALMOLOGY TRENDSFigure 19.What

139、 is the likelihood you would switch a current stable patient on ranibizumab/aflibercept to its biosimilar once it is available?(Surveys conducted in 2020-2021)N=65 Lucentis(ranibizumab)Eylea(aflibercept)12%40%43%17%34%44%5%Over two-thirds of participating retina specialists do not have safety concer

140、ns with off-label,compounded bevacizumab use.For their patients with nAMD,respondents said they would be most likely to prescribe a biosimilar toexisting patients having either success(40%)or limited success(36%)on areference biologic.Very likelySomewhat likelyNot likelyHighly agreeDisagreeAgreeHigh

141、ly disagreeI am not familiar enough with biosimilars to assessOPHTHALMOLOGY TRENDSFigure 21.To what extent do you agree with this statement?The availability of ranibizumab or aflibercept biosimilars will shift utilization away from off-label bevacizumab if price discounts are significant enough.(Sur

142、veys conducted in 2020-2021)N=65 29%17%51%Figure 20.Which statement below best aligns with your perspective regarding compounding/repackaging bevacizumab?(Surveys conducted in 2020-2021)N=65 65%32%3%3%Retina specialists had mixed views on switching stable patients on reference products to biosimilar

143、s.5%I do not have safety concerns with utilizing compounded/repackaged bevacizumab off-label for ophthalmology indications.The cost effectiveness of off-label bevacizumab outweighs any concerns with compounding/repackaging.I have concerns with compounding/repackaging bevacizumab for off-label ophtha

144、lmology use,and do not use it for off-label indications.3233OPHTHALMOLOGY TRENDSOPHTHALMOLOGY TRENDSFigure 22.What will be key decision criteria for using an anti-VEGF biosimilar?(Please select all that apply.)(Surveys conducted in 2020-2021)N=65 45%31%51%17%Figure 23.What would be your primary conc

145、ern with prescribing biosimilars once they become available?(Surveys conducted in 2020-2021)N=102 Not enough financial incentivePayer coverage concernsUncomfortable from a clinical standpointAdministrative barriers(e.g.,prior authorization process)OtherFigure 24.Which of the following would help you

146、 achieve a greater understanding of biosimilars?(Please select up to three.)(Surveys conducted in 2020-2021)N=102 Educational information about safety,efficacy and performanceGuidelines for evaluating when to prescribe a biosimilar vs.reference biologicInformation about discounts to help lower patie

147、nt out-of-pocket costsTrack record of the manufacturer launching the biosimilarAccess to biosimilar and reimbursement-related informationOther12%82%38%41%38%40%9%27%3%47%1%Key influences in future utilization of biosimilars in ophthalmology include cost,payer coverage and clinical data.Cost/Price di

148、scountClinical studies and real-world evidencePayer coverageManufacturers supply reliability3435Physicians and pharmacists see potential for insulin biosimilars to increase access and lower the cost of diabetes careChevon Rariy,MD Vice President and Chair of Virtual Health at Cancer Treatment Center

149、s of America and Medical Director of EndocrinologyTo assess perceptions about the recently approved insulin biosimilars,Cardinal Health conducted a survey of 54 diabetes care providers and 115 pharmacists.The results of this study show that providers(endocrinologists and primary care physicians)agre

150、e that they view the introduction of insulin biosimilars as a likely mechanism to help lower the cost of care for patients with diabetes and that availability of insulin biosimilars is expected to shift utilization away from reference products if price discounts are significant enough.But how much i

151、s significant enough and whom a price discount would benefit remain to be seen.In our survey,for providers to prescribe a biosimilar versus the reference product,a discounted amount of more than 20%would be necessary.Approximately 10%of the U.S.population has a diagnosis of diabetes,type 1 or type 2

152、,and as of 2018,diabetes ranked as the seventh leading cause of death in the U.S.19 To date,over eight million people use insulin daily to effectively manage their diabetes.However,the list price of insulin has continued to rise,nearly tripling since 2001,forcing many patients who face affordability

153、 and other access barriers to self-ration their insulin.20 Uncontrolled blood glucose levels can lead to worsening health complications or even death while at the same time increasing the burden on the health system with costly,otherwise unnecessary hospitalizations.20In 2021,the FDA approved the fi

154、rst insulin biosimilar,insulin glargine-yfgn,under the name Semglee,with an interchangeable designation.The introduction of insulin biosimilars is expected to help cut the cost of insulin,improve access to the medication,and create a win-win-win situation for the patient,care team and overall health

155、care economics.In fact,insulin cost has been a top priority for the Endocrine Society,which recently recommended that the FDA ensure the safety of insulin biosimilars while allowing for approval in an expedited manner.In our study,we saw nearly 40%of physicians expressed discomfort with pharmacists

156、ability to substitute interchangeable biosimilars in place of reference products without first seeking approval from the prescriber.However,pharmacists ability to provide insulin to a patient without delays in therapy and facilitate greater patient adherence in a cost-effective way is in direct alig

157、nment with the goal of increasing access to insulin.In fact,this was the principal reasoning behind the Biosimilar Insulin Access Act of 2020,which focused on the need for insulin biosimilars to be interchangeable with their reference product and,in turn,streamlined the approval process.In our surve

158、y,most pharmacists were comfortable substituting a biosimilar for a reference product if it would deliver lower out-of-pocket costs for the patient,but they expressed concern about both the efficacy of biosimilars and a lack of payer adoption in this substitution.While it is true that interchangeabl

159、e biosimilar insulin products like Semglee could potentially provide cost-effective,safe treatment options for patients with diabetes,providers agreed that payers and PBMs have the most influence in shifting utilization to insulin biosimilars.As insulin interchangeable biosimilar products hit the ma

160、rket,only time will tell if they deliver on their promise of driving costs down.The hope is that they will pave the way for those diabetic patients who have been rationing their insulin to offset high cost and obtain more affordable insulin,thus improving adherence.This would in turn lead to improve

161、d glycemic control,better health outcomes and lower total cost of care for diabetic patients.Moving forward,it is important that we work with patients,caregivers,providers,payers and pharmacists to provide education around insulin biosimilars and interchangeability,including its efficacy and safety,

162、to overcome hesitancy,increase awareness and improve acceptability.DIABETES TRENDSDIABETES TRENDSFigure 25.For which patients are you most likely to substitute an insulin reference product with a biosimilar?(Please select all that apply.)(Surveys conducted in 2021)N=115Nearly 60%of participating pha

163、rmacists said they fill prescriptions daily or weekly for insulin to be used in an insulin pump.Participating pharmacists are slightly more likely to substitute biosimilars for new diabetes patients than for existing patients.New patients for whom the biosimilar insulin is less expensive than the re

164、ference productExisting patients for whom the biosimilar insulin is less expensive than the reference productExisting patients for whom payers have mandated a biosimilarI am not likely to substitute a biosimilar for any patient at this time64%55%52%4%3637DIABETES TRENDSBiosimilars 101 education mate

165、rials(e.g.,1-page reference)Clinical information on biosimilar safety and efficacyRegulatory information on the FDA approval pathway for biosimilarsReimbursement/payer coverage informationInsulin biosimilars product fact sheetsLinks to videos on biosimilar basics that can be sent to prescribersOther

166、;please specify:Figure 27.What types of resources do you feel would be helpful to support your conversations with patients?(Please select all that apply).(Surveys conducted in 2021)N=11571%32%22%43%67%18%0%Less than half of participating pharmacists said they are very prepared for discussing biosimi

167、lars with patients.Figure 26.How prepared do you feel to have conversations with patients on their options for insulin biosimilars?(Surveys conducted in 2021)N=11545%45%10%Very preparedSomewhat preparedNot prepared62%of pharmacists said they would be more likely to substitute a biosimilar if they we

168、re financially incentivized through a Medication Therapy Management(MTM)platform.3839DIABETES TRENDSDIABETES TRENDSFigure 28.Which of the following do you think would help your patients to be more comfortable about switching from a reference product to a biosimilar?(Surveys conducted in 2021)N=115Pr

169、ice incentive37%25%15%23%Prescriber approvalBrief counseling when the patient picks up the prescriptionComprehensive pharmacist-led patient counseling and education(e.g.,Medication Therapy Management MTM,Comprehensive Medication Review CMR)Figure 29.When considering biosimilars as a potential substi

170、tute for a reference product,the importance of cost savings for my patient is:(Surveys conducted in 2021)PharmacistsPhysicians57%0%0%37%6%37%4%0%42%17%Extremely importantSlightly importantNot importantVery importantModerately importantI think the FDA is rushing biosimilars through the approval proce

171、ss without adequate rigor to ensure safety and efficacy.I am comfortable with the FDA approval process for biosimilars.I am comfortable with FDA approval for biosimilars when there is clinical trial evidence,but I have concerns about interchangeability and extrapolation for other indications where t

172、here is no clinical trial evidence.I am not familiar enough with the FDA approval process for biosimilars to assess.Figure 30.Based on your understanding,which of the following statements best describes your perception of the FDA approval process for biosimlars?(Surveys conducted in 2021)Pharmacists

173、Physicians5%2%41%72%39%20%15%6%Half of participating pharmacists(51%)said they are“very comfortable”substituting a biosimilar for a reference product if the biosimilar would deliver a lower out-of-pocket cost for the patient.Participating pharmacists said price incentives are the key factor in promo

174、ting the switch to biosimilars.Participating pharmacists are less comfortable than physicians with the FDA approval process.The majority of physicians and pharmacists view cost savings for patients as extremely or very important.N=115N=54 N=115N=5470%of responding physicians said a discount of 20%or

175、 more would be needed to motivate themto prescribe a biosimilar over a reference product.4041DIABETES TRENDSInsulin biosimilars are likely to lower the cost of care for patients with diabetes.I do not believe insulin biosimilars will significantly impact the cost of diabetes care.I am unsure how the

176、 approval of insulin biosimilars will impact the cost of diabetes care.Figure 31.Which of the following best describes your view on how new insulin biosimilars may impact the cost of diabetes care?(Surveys conducted in 2021)PharmacistsPhysicians74%72%13%15%13%13%Concerns about lack of economic benef

177、itEvaluating when to substitute a biosimilar versus a reference productConcerns about efficacy of biosimilarsLack of payer adoption0%Concerns about manufacturing3%Providing patient education78%of participating pharmacists said favorable economics for the pharmacy are“extremely”or“very”important when

178、 considering biosimilars as a potential treatment option.Participating physicians and pharmacists agree that insulin biosimilars will lower the cost of diabetes care.Figure 32.What is your top concern about substituting a biosimilar product for the reference product?(Surveys conducted in 2021)Effica

179、cy of biosimilars is the top concern for both physicians and pharmacists.Physicians11%7%7%Other7%I do not have concerns prescribing biosimilarsN/A26%15%22%16%28%31%2%21%4%N=115N=54N=115N=54Pharmacists4243DIABETES TRENDSDIABETES TRENDSFigure 33.How would you describe your familiarity with the interch

180、angeability designation for biosimilars?(Surveys conducted in 2021)N=11519%64%Very familiarSomewhat familiarNot very familiarMore than half of participating physicians feel very comfortable prescribing biosimilars to diabetes patients.Less than 20%of participating pharmacists were very familiar with

181、 interchangeability designation.61%of participating physicians said they are comfortable with pharmacists substituting interchangeable biosimilars in place of reference products without prescriber approval.17%4445DIABETES TRENDSFigure 35.Which factor do you think will be the most impactful to shifti

182、ng utilization to insulin biosimilars?(Surveys conducted in 2021)N=54Price discounts20%31%Payer/PBM coverage4%Government regulations18%Price discounts and payer/PBM coverage,equally4%Price discounts and government regulations,equally6%Payer/PBM coverage and government regulations,equally17%Price/dis

183、counts,payer/PBM coverage and government regulations,equallyFigure 34.To what extent do you agree with the following statement?The availability of insulin biosimilars will shift utilization away from reference products if price discounts are significant enough.(Surveys conducted in 2021)N=5441%48%9%

184、0%2%Strongly agreeAgreeNeither agree or disagreeStrongly disagreeDisagreeParticipating physicians said they were either“very familiar”(35%)or“somewhat familiar”(56%)with the interchangeability designation for biosimilars.Nearly nine in 10 participating physicians strongly agree or agree that price d

185、iscounts are key in driving the shift to biosimilars.Participating physicians see payer coverage and price incentives as key factors impacting the shift to biosimilars.4647Payer TrendsJust two years ago,most biosimilar products had very limited payer coverage and were often placed on lower formulary

186、 tiers than their reference product counterparts.Robust biosimilar access will continue to depend on the strategies of managed care stakeholdersWhile payer policies were initially slow to embrace biosimilars in the U.S.,the tide may be starting to turn as payer coverage rates,as well as overall adop

187、tion rates and cost savings,have improved dramatically since 2019.Although significant progress has been made,the journey is far from over.Just two years ago,most biosimilar products had very limited payer coverage and were often placed on lower formulary tiers than their reference product counterpa

188、rts.21 These formulary and utilization management strategies,such as prior authorizations and step therapy (See Figure 41-1 for definitions),while key tools to help managed care stakeholders predict utilization and lower drug costs,can slow the adoption of biosimilars and restrict patient access to

189、these products.Without equivalent coverage in payer medical policies or PBM formularies at minimum,biosimilars stand at a significant access disadvantage compared to their reference products.PAYER TRENDSJeff Baldetti,MBADirector of Biosimilars Cardinal Health4849PAYER TRENDSPAYER TRENDSAs a result,e

190、arly adopters of biosimilars often had to navigate complex administrative and inventory challenges associated with carrying multiple therapeutically equivalent treatment options to provide biosimilars to their patients.Utilization management strategies like prior authorizations and step edits are st

191、ill widely used today,but these policies are beginning to move in favor of biosimilars.As shown in Figures 36-41,almost every biosimilar had a lower average coverage score than its reference product in 2019,meaning providers and patients had to take additional steps to access biosimilars.Today,biosi

192、milars are beginning to gain greater utilization,with much of this change driven by more favorable coverage policies from managed care entities.By November 2021(as shown by the red bars in Figures 36-41),almost every biosimilar had experienced a dramatic increase in its coverage score.In many cases

193、the coverage scores of the biosimilars now exceed the score of their reference products,while at the same time,most reference products have seen moderate coverage score decreases.In aggregate,it is safe to say that payer coverage for biosimilar treatments has improved greatly over the last two years

194、,likely contributing to the rise in adoption rates.While it is clear that biosimilar adoption is greatly influenced by payer coverage decisions,what is striking is how closely these coverage scores and adoption rates can move in lockstep.As illustrated in Figure 42,by plotting biosimilar adoption ra

195、tes in the market against the aggregate percentage of lives where the biosimilars are considered in a covered or better position in the U.S.,there is an astonishing 97%correlation.While correlation does not always represent a causal effect,the close alignment between these two metrics reminds us tha

196、t the success of biosimilars is a multi-stakeholder responsibility.Payer coverage for biosimilar treatments has improved greatly over the last two years,likely contributing to the rise in adoption rates.Aggregate Coverage Scores for Biosimilars and Reference Products Over TimeMany commercial payers

197、utilize formulary and utilization management tools to control costs and better predict product use in their member populations.However,the variation in utilization management strategies by product and payer can sometimes create additional steps before patients can access specific treatments.Provider

198、s are often tasked with navigating several payer policies when evaluating biosimilars,as their patient populations are often represented by a variety of payers.Insights into these payer strategies provide added nuance to better understand how well covered,and therefore how accessible,certain product

199、s like biosimilars are for patients.Using data accumulated from payer formularies and medical policies at the aggregate U.S.level,this analysis reviewed how coverage of biosimilars and their reference products have changed over the two-year period between December 2019 and November 2021(collectively

200、,Figures 36-41).For this exercise we looked specifically at a spectrum ranging from full product coverage with no step therapy requirements(6=best coverage available)to no product coverage or unknown coverage(1=worst coverage available).We can call these“coverage scores.”Higher coverage scores equat

201、e to overall better coverage for a product,whereas lower coverage scores equate worse coverage for a product.Figure 36.Therapeutic oncology Avastin(bevacizumab)and related biosimilars December 2019 The payer coverage levels for biosimilars have increased significantly since 2019 while levels for ref

202、erence products have generally declined.Figure 37.Therapeutic oncology Rituxan(rituximab)and related biosimilarsDecember 20194.55.45.44.35.41.93.63.6Rituxan-ReferenceRuxienceTruximaRiabniSource:Managed Markets Insight&Technology,LLC(MMIT)Analytics Accessed November 2021.November 2021November 20214.5

203、5.45.05.24.83.2Avastin-ReferenceMvasiZirabevBestNot covered or unknown123456 BestNot covered or unknown123456 5051PAYER TRENDS4.24.25.44.44.34.55.34.1Neupogen-ReferenceGranix*ZarxioNivestymFigure 39.Supportive care oncology Neupogen(filgrastim)and related biosimilars December 2019Source:Managed Mark

204、ets Insight&Technology,LLC(MMIT)Analytics Accessed November 2021.As the biosimilars market continues to evolve,it is no longer a question of “if”the biosimilar will have coverage,but“which”biosimilar product from the slate of FDA approved options will have the best coverage with each payer.Providers

205、 and administrators will still be tasked with navigating the complexities of payer policies that vary by payer,region and therapeutic area,but biosimilars will now be more competitively positioned alongside reference products.It is also important to note that,while all of the approved biosimilars fo

206、r the last six years have been products administered in a hospital or physician clinic under the medical benefit,the next wave”of biosimilars will be available in the retail/specialty pharmacy channel and primarily covered under the pharmacy benefit.With the approval and official relaunch of the fir

207、st interchangeable biosimilar in November 2021 a long-acting insulin,Semglee Viatris made the decision to commercialize two versions of their landmark interchangeable product,including a branded,high list price product(5%discount to Lantus),and an unbranded,low list price product(65%discount to Lant

208、us).While it is clear that biosimilar adoption is greatly influenced by payer coverage decisions,what is striking is how closely these coverage scores and adoption rates can move in lockstep.Figure 38.Therapeutic oncology Herceptin(trastuzumab)and related biosimilars December 20194.65.34.44.44.65.33

209、.54.64.83.53.43.0OgivriKanjintiHerceptin-ReferenceHerzumaOntruzantTrazimera*Granix is not a true biosimilar since it was not approved through the Biosimilar 351(k)pathway.November 2021November 2021BestNot covered or unknown123456 BestNot covered or unknown123456 5253As noted in Figure 41,Semglee had

210、 a very low average coverage score,despite its attractive list price.However,recent announcements from major PBMs seem to show that Viatris dual product approach could prove more effective in driving payer coverage the second time around.Thus far,two major PBMs(Express Scripts and Prime Therapeutics

211、)have publicly stated plans to include the interchangeable insulin biosimilar as the preferred agent on their national preferred formularies(NPFs)starting in 2022.Express Scripts will shift the branded version of interchangeable Semglee to preferred status on their NPF,22 and Prime Therapeutics will

212、 shift both the branded and unbranded versions of Viatris interchangeable biosimilar to preferred status on their NPF.23 Both PBMs will plan to move the reference product,Lantus,to non-covered status.While these early moves are encouraging,it is likely many additional payers and PBMs will continue t

213、o take a“wait and see”approach to evaluating these new interchangeable biosimilars.As more interchangeable products come to market over the next several years,managed care stakeholders,specifically PBMs,will have to navigate how these lower-cost biosimilar products,which often cannot support the sam

214、e level of discounts and rebates that branded biologics can,fit into the landscape.These strategic choices made by managed care stakeholders will in turn continue to influence the strategic choices biosimilar manufacturers take as they plan future commercial launches.However,one thing is clear until

215、 coverage increases more broadly,we will likely see slower than expected adoption in the pharmacy benefit biosimilars.While there is no playbook of best practices that can be applied directly from the medical benefit to the pharmacy benefit,we know that the success of biosimilars in any therapeutic

216、area or channel depends on many stakeholders,with payers playing a significant role in shaping access to products.Insulin biosimilars will serve as a key learning experience for all biosimilars to follow in the Part D space and likely will lay the foundation for competition in the pharmacy benefit f

217、or years to come.As more payers implement favorable biosimilar policies,the ultimate promise of biosimilars becomes a more likely reality:increased competition,lower prices and greater patient access to high-quality treatment options.Managed care stakeholders hold the key to realizing much of the sa

218、vings potential of biosimilars and can accelerate,or hinder,their progress.Without adequate coverage,patients will struggle to gain access to these high-quality,potentially lower-cost treatment options.Widespread access to biosimilars is arguably the most vital piece to bending the cost curve for co

219、mplex biologic treatments and paving the way for the next wave of therapeutic innovations in the U.S.Figure 40.Supportive care oncology Neulasta(pegfilgrastim)and related biosimilarsDecember 20194.94.55.14.54.14.34.95.11.8UdencyaFulphilaNeulasta-ReferenceZiextenzoNyvepriaFigure 41.Diabetes care Lant

220、us(insulin glargine)and related biosimilarsDecember 2019November 20214.63.81.44.44.0Lantus-ReferenceBasaglar*Semglee PenPAYER TRENDSPAYER TRENDSPrior authorization:Is a utilization management strategy used by payers to review a prescribers intended treatment option for their patient“prior to”dispens

221、e/administration to decide whether the insurer will reimburse or cover the patients treatment.If prior authorization is denied,prescribers must resubmit additional documentation or choose a different treatment option for their patient(e.g.,an alternative drug).Step therapy(Step edits):Is a utilizati

222、on management strategy used by payers to define the sequence of drug products a patient must“step through,”or fail first on,before they can access a certain drug product.Generally,patients are required to fail treatment first on a cheaper treatment option before moving on to more expensive options.S

223、emglee(Insulin glargine):The FDA first approved Semglee under the generic 505(b)(2)New Drug Application pathway in June 2020,and then the product was automatically deemed a biologic under section 351(a),based on a policy enacted March 2020 that transitioned insulins,and several other products,to be

224、regulated as biologics.In July 2021,the FDA officially approved Semglee(insulin glargine-yfgn)as an interchangeable biosimilar via the 351(k)pathway.The relaunch of Semglee(insulin glargine-yfgn)and its unbranded version,Insulin Glargine-yfgn,took place in November 2021.Managed care stakeholders hol

225、d the key to realizing much of the savings potential of biosimilars and can accelerate,or hinder,their progress.Source:Managed Markets Insight&Technology,LLC(MMIT)Analytics Accessed November 2021.Source:Managed Markets Insight&Technology,LLC(MMIT)Analytics Accessed November 2021.November 2021Figure

226、41-1.Terms related to payer coverage.BestNot covered or unknown123456 BestNot covered or unknown123456*Basaglar is not a true biosimilar since it was not approved through the Biosimilar 351(k)pathway.Note:Nyvepria,Avsola,and Semglee had not launched by Dec.2019 and therefore does not have a blue bar

227、.5455A strong correlation is shown between biosimilar adoption and increases in payer coverage.As an example,there is a 97%correlation between Rituxan biosimilars adoption and the percentage of plans covering Rituxan biosimilars at parity or in preferred positions.PAYER TRENDS0Dec 19Jan 20Jan 21Feb

228、20Feb 21Mar 20Mar 21Apr 20Apr 21May 20May 21Jun 20Jun 21Jul 20Jul 21Aug 20Aug 21Sep 20Sep 21Oct 20Nov 20Dec 2010203024435481818343405060708090100Figure 42.Rituxan Biosimilars Adoption vs.%of Covered or Better StatusBiosimilar Coverage (%Lives Covered/Preferred)RituxanRuxienceTruximaRiabniNote:Red li

229、ne represents the percentage of aggregate lives in the U.S.where their payer carries Rituxan biosimilars at a covered or better status.Sources:Managed Markets Insight&Technology,LLC(MMIT)Analytics Accessed November 2021 and IQVIA:Accessed via IQVIA National Sales Perspective(NSP)SMART Data.(October

230、2021).Biosimilar unit share(%)5657Five Biosimilar Predictions for 2022Biosimilars are forecasted to deliver over$133 billion in aggregate savings by 2025,24 and more importantly,total savings to patient out-of-pocket costs based on just the current biologics with biosimilars approved are estimated t

231、o reach up to$238 million.25 With more than 40 different reference products being discussed for biosimilar development,the momentum around bringing biosimilars to market is stronger than ever.262022 is set to be a turning point in the U.S.as biosimilars expand into new therapeutic areas and sites of

232、 care and reimbursement models continue to evolve.While biosimilars were primarily focused on oncology and to a lesser extent rheumatology during the past seven years,the next five years will focus on the opportunities to bring biosimilars to a broader patient population across diabetes,ophthalmolog

233、y,and most notably,immunology.The year ahead is sure to include many significant biosimilar milestones;we predict the following five trends will be particularly worth watching.Heidi HunterPresident,Cardinal Health Specialty Solutions1.Insulin biosimilars will reveal how managed care stakeholders wil

234、l respond to interchangeable biosimilars,and retail pharmacists will be positioned as key change agentsAs the first biosimilar product to fall under the pharmacy benefit in the Part D space,insulin will serve as the ultimate case study to reveal how the managed care landscape will evaluate and posit

235、ion these products and how payers and PBMs will design plans and formularies to deliver the greatest savings to patients,a much-debated topic.Without robust coverage for biosimilars,the extent of cost savings and intended benefit of the interchangeability designation may be limited for patients.Mana

236、ged care stakeholders have the opportunity to be catalysts for biosimilar adoption,bringing much-needed competition to the market.The question of how quickly they will embrace this opportunity is likely to be answered this year.Retail pharmacists also will play a critical role in delivering the prom

237、ise of biosimilars on behalf of their patients and communities.With Semglee(insulin glargine-yfgn)designated as interchangeable,pharmacists can substitute it in place of its reference product without prior prescriber approval,per state laws.As a result,pharmacists are now positioned to not only play

238、 an essential role in educating patients and ensuring clinical confidence in biosimilars,but also to serve as key change agents who may steer millions of diabetes patients to high-quality,lower-cost treatment options.5859LOOK AHEADLOOK AHEAD2.Manufacturers of reference biologics will take further st

239、eps to protect market share in preparation for the launch of Humira biosimilars in 2023Beginning next year,AbbVies Humira(adalimumab)the all-time top selling drug in the world27 will face competition from up to seven biosimilar competitors that have already received FDA approval,as well as several m

240、ore candidates in the pipeline.The impact on the rheumatology and immunology market as a whole could be dramatic not just for Humira but for all immunology therapies in the class,including Janssens Stelara(ustekinumab)and Genentechs Actemra(tocilizumab),which are also anticipated to face biosimilar

241、competition over the next few years.Several innovator biologic companies have already taken steps to defend their market position by raising prices,creating new formulations or by generating new innovative therapies.According to a 2021 report from the House Committee on Oversight and Reform,the list

242、 price of Humira had increased 27 times,leading to a price that is 470%higher than when the drug launched in 2003.28 Other reference product manufacturers have employed similar pricing strategies.As a result,when biosimilars come to market,the branded biologic manufacturers will be in a position to

243、offer deep rebates to payers and PBMs,which may in turn keep its net price on par or even lower than biosimilar competitors.Innovator companies have also added new formulations and delivery mechanisms,such as autoinjector devices,29 which,in addition to providing patients with more treatment options

244、,also extend patent protection.We expect to see continued advancements in innovator formulations and administration mechanisms in 2022 and beyond.We will also see more focus from innovator companies on transitioning patients to completely new treatment options,seeking to advance the path toward obso

245、lescence of biosimilars and originator biologics as a whole.It is also likely that several branded biologic companies may introduce their own“authorized biologic”versions of their products at a lower price in advance of the biosimilars launching,which could protect patient share and help fend off co

246、mpetition.At the same time,the manufacturers of the adalimumab biosimilars have a lot to potentially gain in 2023 and they know the competition for share will be fierce.We anticipate some may be launching market conditioning and educational campaigns over the next year to establish brand awareness a

247、nd educate prescribers,patients and pharmacists in advance of their arrival in 2023.The next five years will focuson the opportunities to bring biosimilars to a broader patient population across diabetes,ophthalmology,and mostnotably,immunology.3.Biosimilar uptake in ophthalmology will be slow,as th

248、e focus on innovating in retinal care continuesThe number of patients diagnosed with wet age-related macular degeneration(AMD),the worlds leading cause of blindness in older adults,is continuing to grow annually with the National Eye Institute predicting the number of cases will more than double by

249、2050.With an average annual cost of$2,000 per treatment,the biotech industry is focused on developing more effective AMD therapies and delivering treatment options that lower the cost of care.30 The latter of these goals may start to be addressed by the launch of Byooviz(ranibizumab-nuna),the first

250、biosimilar in ophthalmology,which was approved in September 2021 and expected to launch in June 2022.While the entrance of biosimilars to Lucentis(ranibizumab)brings the potential for broader treatment access and lower costs for AMD patients,we anticipate biosimilar uptake in ophthalmology may be sl

251、ower than other therapeutic areas for several reasons.First,the U.S.achieved one of the first ophthalmology biosimilar approvals in the world(unlike oncology and rheumatology biosimilars,which were initially approved in Europe),meaning there is limited real-world data for physicians to reference.Res

252、earch conducted with ophthalmologists and retina specialists in 2021 shows a high level of skepticism about biosimilars,indicating a strong need for education and additional outcomes data to help build confidence among prescribers.31Another factor that will impact adoption of biosimilars in ophthalm

253、ology is the innovator therapies that have recently launched or are expected to come to market soon to treat AMD,including Roches new port delivery system,Susvimo with ranibizumab,32 faricimab and several gene therapies in development.33 As these new,and possibly more effective,treatments come to ma

254、rket,physicians will have more options to select from and standards of care for AMD will continue to evolve.While launch of new innovative therapies could lead to slower uptake of biosimilars,they should also lead to a wider range of treatment options and better outcomes for patients.60614.The U.S.w

255、ill see more pro-biosimilar healthcare policies at both the federal and state levelsIn 2021,President Biden demonstrated strong support for biosimilars.In addition to signing an Executive Order directing the FDA to make the biosimilar approval process more transparent,his administration also called

256、for market changes that would promote biosimilars in a report outlining the administrations recommendations on lowering the cost of prescription drugs.34We expect to see more pro-biosimilar focus in the future,including additional rulemaking by the FDA as well as Federal Trade Comission(FTC)action t

257、o support competition and enhance consumer choice by preventing efforts by reference product manufacturers to delay or block competition from biosimilar and interchangeable products.As well,per the October 2021 white paper“Innovation Strategy Center Refresh,”35 we anticipate the Center for Medicare

258、and Medicaid Innovation Center(CMMI)to design models that incentivize the use of biosimilars in Medicare Parts B and D to lower beneficiary and program spending on drugs.CMS may also issue guidance to ensure that biosimilars are covered under Medicare Part D and pursue additional policies,such as re

259、moval of prior authorizations and other utilization hurdles,and reductions in patient cost sharing to drive increased adoption.In addition,as states continue their efforts to lower drug costs,we expect state legislatures in 2022 to introduce policies that will broaden access to biosimilars,such as r

260、equiring health plans and pharmacy benefit managers to cover all versions of biological agents,including biosimilars.LOOK AHEADof biosimilars experience in the EU,36 sharing of global resources and data represents one of the greatest opportunities to strengthen biosimilar acceptance in the U.S.We al

261、so expect RWE to play a key role in advancing the development and approval of biosimilars that are early in the pipeline and providing data to help products meet the regulatory standards necessary for interchangeability designation.Looking beyond 2022,the successful adoption of biosimilars will not

262、only create broader healthcare access and lower costs for patients,but also free healthcare dollars systemwide to enable more investment in advanced,innovative treatments,such as cell and gene therapies,with the potential to drive overall improvements in both rare diseases and public health.Although

263、 there are still barriers to overcome,the promise of biosimilars outlined in the Biologics Price Competition and Innovation Act(BPCIA)are starting to be realized.And as momentum around biosimilars in the U.S.continues to accelerate,patients will experience expanded benefits through broader access to

264、 and affordability of life saving medications.5.Biosimilars manufacturers and commercial partners will increasingly turn to real-world evidence(RWE)to demonstrate equivalency to providers and payersWhile understanding of biosimilars among prescribers continues to grow,many healthcare providers still

265、 question whether biosimilars can deliver the same outcomes for patients as their reference products.As biosimilar manufacturers face increased pressure to demonstrate safety and efficacy,they will increasingly invest in RWE studies,which are not only less expensive to implement than randomized cont

266、rolled trials,but also more representative of the patient populations in the real world.This data will be particularly relevant in ophthalmology,where there is limited RWE available.RWE studies will also provide valuable insights into whether switching patients between biosimilars of the same molecu

267、le has an impact on patient outcomes,which will become a more important question as more biosimilars come to market specifically in categories such as immunology where there could be seven or more biosimilars referencing a single branded product.In addition,with more than 15 years and two billion pa

268、tient days 6263LOOK AHEADLOOK AHEAD1Immunology(e.g.,RA/GI/Derm/Neuro)DiabetesBone HealthOphthalmologySupportive Care#Year the first anticipated biosimilar launches Reference Biologic(molecule)Number of biosimilars either in phase III trials,pending FDA approval or FDA approved2021Lantus(insulin glar

269、gine)42022Lucentis(ranibizumab)42022/2023Neulasta Onpro(pegfilgrastim)32023/2024Stelara(ustekinumab)52025Soliris(eculizumab)12024Simponi(golimumab)12029Enbrel(etanercept)32022/2023Actemra(tocilizumab)22022NovoLog(insulin aspart)22023Humira(adalimumab)102023/2024Eylea(aflibercept)72025Prolia/Xgeva(de

270、nosumab)520222023202420252026+Note:Data reflects biosimilar pipeline information as of January 2022.For updates,please visit 43.New and upcoming biosimilars launchesSource:IPD Analytics.Market&Financial Insights.December 2021.https:/.6465LOOK AHEADLOOK AHEAD20231.31.2023Amjevita(Amgen)7.1.2023Cyltez

271、o(Boehringer Ingelheim)7.1.2023Yusimry(Coherus)7.31.2023Hulio(Viatris/Biocon)TBD*AVT02(Alvotech/Teva)TBD*CT-P17(Celltrion)7.1.2023Hadlima(Organon/Samsung Bioepis)*pending approval*pending approvalFor a more detailed Humira biosimilar landscape overview,please visit: reflects biosimilar pipeline info

272、rmation as of January 2022.For updates,please visit 44.Humira(adalimumab)biosimilars pipelineTo be determined11.20.2023Abrilada(Pfizer)9.30.2023*Idacio(Fresenius Kabi)*pending approval9.30.2023Hyrimoz(Sandoz)Source:IPD Analytics.Market&Financial Insights.December 2021.https:/.Date of anticipated lau

273、nchBiosimilar(Manufacturer)6667Expert ContributorsSonia T.Oskouei,PharmD,BCMAS,DPLA,is Vice President of Biosimilars for Cardinal Health,where she leads the national biosimilars strategy to enhance patient access to therapy and lower the cost of care.A board-certified Medical Affairs Specialist,Dr.O

274、skouei was previously Vice President of Innovation and Digital Health at Premier Inc.,where she also led their biosimilars strategy on behalf of 4,000 hospitals and 175,000 other provider types.She received her Doctor of Pharmacy from Belmont University and completed post-graduate residencies in Cli

275、nical Pharmacy and Health System Pharmacy Administration.She serves on the Board of Advisors for the Center of Biosimilars and frequently speaks and publishes on biosimilars.Gordon Lam,MD,FACR,is Medical Director of Clinical Research at Arthritis&Osteoporosis Consultants of the Carolinas.He is board

276、-certified in Internal Medicine and Rheumatology and is a fellow of the American College of Rheumatology.Dr.Lam has 19 years of clinical and translational research with various institutions,including Princeton University,Duke University,the National Institutes of Health,the Arthritis Foundation,the

277、Howard Hughes Medical Institute and Atrium Health.He has participated in clinical studies for rheumatoid arthritis,Sjogrens syndrome,gout,spondylarthritis and HIV,and has numerous peer-reviewed publications,book chapters and abstracts.Nancy M.Holekamp,MD,is Director of Retina Services at the Pepose

278、Vision Institute in St.Louis,Missouri.Prior,she was Professor of Clinical Ophthalmology at the Washington University School of Medicine in St.Louis,Missouri.She has been a principal investigator in more than 38 national clinical trials dealing with age-related macular degeneration,retinal vascular o

279、cclusion and diabetic retinopathy.Her efforts in research have resulted in 80 peer-reviewed publications,22 book chaptersand more than 125 speaking invitations.She has received the Senior Honor Award and the Secretariat Award from the American Society of Retina Specialists,and well as the Senior Hon

280、or Award from the American Academy of Ophthalmology.Bruce Feinberg,DO,has served as Vice President/Chief Medical Officer for Cardinal Health Specialty Solutions for the past 10 years.Dr.Feinberg was previously founder and CEO of Georgia Cancer Specialists(GCS),one of the largest integrated oncology

281、specialty practices in the southeastern U.S.He is a board-certified medical oncologist in Georgia where he practiced for 25 years after completing his fellowship at MD Anderson Cancer Center.A sought-after research and speaker,Dr.Feinberg has more than 200 peer-reviewed publications on a broad range

282、 of topics.He is also the author of the bestselling Breast Cancer Answers and host of The Weekly Check-Up on Atlantas WSB Radio.Chevon Rariy,Vice President and Chair of Virtual Health at Cancer Treatment Centers of America and Medical Director of Endocrinology.Board certified in internal medicine,en

283、docrinology,diabetes and metabolism,Dr.Rariy is responsible for developing new telehealth offerings and overseeing the diagnosis and treatment of a range of endocrine disorders.She earned her medical degree from Harvard Medical School,completed a residency in internal medicine at the Hospital of the

284、 University of Pennsylvania,completed fellowship training at Brigham&Womens Hospital in Boston and University of Pittsburgh Medical Center.She has won numerous awards for her clinical research and advancements in virtual care,including the CTCA Chairmans Award for her contributions in telehealth.Jef

285、f Baldetti,MBA,serves as Director of Biosimilars at Cardinal Health with responsibility for leading the retail biosimilars strategy.His previous roles include working as a Senior Consultant on Cardinal Healths Corporate Strategy and Innovation team,where he supported the development of the biosimila

286、rs strategy;and serving as a High Yield Analyst at a long/short hedge fund.Jeff has an MBA from The Ohio State University,a BSBA from Elon University,and has completed continuing education through the Harvard Business School Online.Heidi Hunter,MBA,is an accomplished global healthcare leader with de

287、ep experience in innovation,development and commercialization of specialty pharmaceuticals.As President of Cardinal Health Specialty Solutions,she works with healthcare providers and pharmaceutical companies to drive business growth and improve patient outcomes.She previously served as Senior Vice P

288、resident and General Manager at Boehringer Ingelheim,where she built and led their global biosimilars business.She also held senior commercial roles at UCB in Brussels;Centocor,a J&J company,and Wyeth Pharmaceuticals.She holds an MBA from The University of Chicago and a bachelors degree in economics

289、 and German from The University of Michigan.6869References1 Medgadget.(2021,August 18).Europe Biosimilars Market Sales Size Clinical Trials USD 10 Billion Opportunity.Retrieved from M:https:/ Association for Accessible Medicines.(2021,October).2021 U.S.Generic and Biosimilar Medicines Savings Report

290、.Retrieved from Association for Accessible Medicines:Generics&Biosimilars:https:/accessiblemeds.org/sites/default/files/2021-10/AAM-2021-US-Generic-Biosimilar-Medicines-Savings-Report-web.pdf3 Association for Accessible Medicines.(2021,September 21).Study Finds U.S.Generic and Biosimilar Savings Tot

291、aled A Record$338 Billion in 2020.Retrieved from Association for Accessible Medicines:Generics&Biosimilars:https:/accessiblemeds.org/resources/press-releases/study-finds-us-generic-and-biosimilar-savings-totaled-record-338-billion4 U.S.Department of Health and Human Services.(2021,September 9).HHS S

292、ecretary Xavier Becerra Releases Bold Proposal to Lower Prescription Drug Costs.Retrieved from U.S.Department of Health and Human Services:https:/www.hhs.gov/about/news/2021/09/09/hhs-secretary-xavier-becerra-releases-bold-proposal-lower-prescription-drug-costs.html5 IQVIA Institute for Human Data S

293、cience.(2021,May).The Use of Medicines in the U.S.:Spending and Usage Trends and Outlook to 2025.Retrieved from IQVIA:https:/ Herkert D,Vijayakumar P,Luo J,et al.Cost-Related Insulin Underuse Among Patients With Diabetes.JAMA Intern Med.2019;179(1):112114.doi:10.1001/jamainternmed.2018.50087 Farmer,

294、J.,&ONeill Hayes,T.(2020,April 2).Insulin Cost and Pricing Trends.Retrieved from American Action Forum:https:/www.americanactionforum.org/research/insulin-cost-and-pricing-trends/8 Biogen.(2021,September 21).FDA Approves Samsung Bioepis and Biogens BYOOVIZ(SB11),LUCENTIS Biosimilar(ranibizumab-nuna)

295、.Retrieved from Biogen:https:/ Cardinal Health,2021.Ophthalmology Survey.10 The White House.(2021,April 21).Bills Signed:S.164,S.415,S.422,S.578.Retrieved from The White House:https:/www.whitehouse.gov/briefing-room/legislation/2021/04/23/bills-signed-s-164-s-415-s-422-s-578/11 Becerra,X.(2021,Septe

296、mber 9).Comprehensive Plan for Addressing High Drug Prices.Retrieved from Office of the Assistant Secretary for Planning and Evaluation:https:/aspe.hhs.gov/sites/default/files/2021-09/Competition%20EO%2045-Day%20Drug%20Pricing%20Report%209-8-2021.pdf12 Oskouei,S.T.,&Kusmierczyk,A.R.(2021).Biosimilar

297、 Uptake:The Importance of Healthcare Provider Education.Pharmaceutical medicine,35(4),215224.https:/doi.org/10.1007/s40290-021-00396-713 Nabhan C,Parsad S,Mato AR,Feinberg BA.Biosimilars in Oncology in the United States:A Review.JAMA Oncol.2018;4(2):241247.doi:10.1001/jamaoncol.2017.200414 AJMC:The

298、Center for Biosimilars.(2021,June 8).Study:OCM Reduces Use of Some Supportive Care Medications and Boosts Filgrastim Biosimilar Use.Retrieved from AJMC:The Center for Biosimilars:https:/ Information accessed and analyzed through the IQVIA SMART Data Analytics Platform;subscription required to access

299、 data16 Centers for Medicare and Medicaid Services.(2021,October).Addendum A and Addendum B Updates.Retrieved from https:/www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates17 IQVIA SMART Data Analytics Platform.Accessed September 2021.Subscr

300、iption required to access data18 Department of Health and Human Services,Office of Inspector General.(2012,April).Medicare Payments for Drugs Used to Treat Wet Age-Related Macular Degeneration.Retrieved from https:/oig.hhs.gov/oei/reports/oei-03-10-00360.pdf19 American Diabetes Association.(2018).St

301、atistics About Diabetes.Retrieved from American Diabetes Association:https:/www.diabetes.org/resources/statistics/statistics-about-diabetes20 Cefal,W.T.,Dawes,D.E.,Gavlak,G.,Goldman,D.,Herman,W.H.,Nuys,K.V.,.Yatvin,A.L.(2018).Insulin Access and Affordability Working Group:Conclusions and Recommendat

302、ions.Diabetes Care,41;12991311.21 Managed Markets Insight&Technology,LLC(MMIT)Analytics Accessed November 202122 Evernorth.(2021,October 20).Express Scripts Will Unlock$20 Million in Savings for Clients in 2022 by Preferring the First Interchangeable Insulin Biosimilar.Retrieved from Evernorth:https

303、:/ AJMC The Center for Biosimilars.(2021,November 4).Prime Therapeutics Joins Express Scripts in Moving Semglee to Preferred Formulary Status.Retrieved from AJMC The Center for Biosimilars:https:/ reference 2)25 Winegarden,W.(2020).Promoting Biosimilar Competition to Reduce Patients Out-of-Pocket Co

304、sts.San Francisco:Pacific Research Institute.26 Eglovitch,J.S.(2021,May 28).Woodcock cites vigorous interest in biosimilar development.Retrieved from Regulatory Affairs Professionals Society:https:/www.raps.org/news-and-articles/news-articles/2021/5/woodcock-cites-vigorous-interest-in-biosimilar-dev

305、27 Fierce Pharma.(2021,Mary 3).Top 20 Drugs by 2020:Humira.Retrieved from Fierce Pharma Special Report:https:/ U.S.House of Representatives Committee on Oversight and Reform.(2021,May).Drug Pricing Investigation:Abbvie-Humira and Imbruvica.Retrieved from https:/oversight.house.gov/sites/democrats.ov

306、ersight.house.gov/files/Committee%20on%20Oversight%20and%20Reform%20-%20AbbVie%20Staff%20Report.pdf29 Lynch,M.(2018,November 28).Giving patients a choice:Genentech RA auto-injector product approved in US.Retrieved from Biopharma-Reporter:https:/www.biopharma- National Eye Institute.(2019,July 17).Ag

307、e-Related Macular Degeneration(AMD)Data and Statistics.Retrieved from https:/www.nei.nih.gov/learn-about-eye-health/outreach-campaigns-and-resources/eye-health-data-and-statistics/age-related-macular-degeneration-amd-data-and-statistics31 Oskouei,S.(2021,January 16).Opinion:Is the Ophthalmology Mark

308、et Ready to Embrace Biosimilars?Retrieved from:https:/ Roche.(2021,October 22).FDA approves Roches Susvimo,a first-of-its-kind therapeutic approach for neovascular or“wet”age-related macular degeneration(nAMD).Retrieved from Roche Media Releases:https:/ Dunaief,J.(2021,August 16).Update on the Age-R

309、elated Macular Degeneration(AMD)Drug Pipeline.Retrieved from BrightFocus Foundation:https:/www.brightfocus.org/macular/article/update-on-the-age-related-macular-degeneration-drug-pipeline34 The White House.(2021,July 9).Executive Order on Promoting Competition in the American Economy.Retrieved from

310、https:/www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/35 Center for Medicare and Medicaid Services.(2021,September).Innovation Center Strategy Refresh.Retrieved from https:/innovation.cms.gov/strategic-direction-white

311、paper36 Medicines For Europe.(2020).The total clinical experience with biosimilar medicines exceeds 2 billion patient treatment days.Retrieved from https:/ healthcare provider research was conducted by Cardinal Health using web-based surveys in 2020 and 2021.The oncology surveys were fielded in Sept

312、ember,October and November 2020,and February 2021,and included more than 320 oncologists.The rheumatology surveys were fielded in February and March 2020 and included more than 100 rheumatologists.The ophthalmology surveys were fielded in September 2020 and January and February 2021 and included mor

313、e than 100 retina specialists.The diabetes surveys were fielded in November and December 2021 and included more than 50 physicians(endocrinologists and primary care physicians who treat diabetes)and 115 pharmacists.About Cardinal Health and BiosimilarsWith broad access to biosimilars and a deep unde

314、rstanding of the considerations for biosimilar utilization,Cardinal Health is positioned to be your trusted healthcare advisor and partner.For specialty physician practices,hospitals,health systems and pharmacies,we not only distribute products we also deliver the insights,tools and expert support p

315、roviders need to evaluate biosimilars for adoption,enabling them to make clinically sound and cost-effective treatment decisions.For biopharma companies bringing new biosimilars to market,our capabilities support the product lifecycle from pre-clinical to post-commercial launch.Our team of seasoned

316、experts works to accelerate and simplify the process to achieve commercial success with guidance on regulatory approval pathways,real-world evidence generation,educational programs and market insights,logistics planning and implementation,and patient hub services to support patients through their tr

317、eatment journey.Cardinal Health works with all healthcare stakeholders,including providers,payers,pharmacists,biopharma companies,policy makers and patients,to provide education and build a broader understanding of the role that biosimilars can play in facilitating high-quality,lower cost care.Learn more about our solutions and resources at Cardinal Health.All Rights Reserved.CARDINAL HEALTH and the Cardinal Health LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries.Patent our website to access biosimilars resources,solutions,and