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1、1AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024The U.S.Generic&Biosimilar Medicines Savings ReportS E P T E M B E R 2 0 2 42AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024INTRODUCTIONLetter From the President and CEOProtecting Patients for the Next 40 Years and BeyondOn th

2、e eve of the 40th anniversary of the Drug Price Competition and Patent Restoration Act,commonly known as the“Hatch-Waxman Act,”we stand at a critical crossroads.Will we enact policies that support another forty years of a vibrant generic market,enabling patients to access the medicines they need?Or

3、will we allow anti-competitive behavior and the suppression of generic medicines to continue?Will we fight to continue to provide low-cost medications to all patients,including the most vulnerable populations and those who need them most?Or will we force more manufacturers to exit markets and exacer

4、bate shortages of lifes-saving drugs?I am pleased to share AAMs latest annual savings report highlighting the overall value of the generic and biosimilar industry.This report is the culmination of a continued collaboration with the IQVIA Institute for the past 14 years.Together,generic and biosimila

5、r drugs represent a whopping 90 percent of all U.S.prescriptions for only 13 percent of spending.In the context of all healthcare spending,generics and biosimilars represent only one percent of the U.S.healthcare expenses.With manufacturing facilities located in nearly half of U.S.states from Califo

6、rnia,to New Jersey,from Illinois,to North Carolina and beyond todays generic drug industry makes it easier for patients to afford their medicines.We help employers pay for healthcare to keep our American workforce healthy,and we help health plans contain spending.Generic and biosimilar manufacturers

7、 form an integral and essential part of the healthcare system.As a result,the United States leads the world in both pharmaceutical innovation and adoption as well as access to lower-cost generic drugs.The long-term sustainability and success of these industries and the very health of our nations pat

8、ients hang in the balance.The rate of drug shortages has increased as manufacturers face challenges including rapid price deflation,supply chain challenges,Medicaid rebate policies that harm generic competition,slower adoption of new products due to abusive pharmacy benefit manager(PBM)financial eng

9、ineering,and brand drug patent thickets.We cannot afford to take our generic and biosimilar industries for granted.We must do better!David R.Gaugh Interim President&CEO,Association for Accessible Medicines3AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Letter from the Biosimilars Counci

10、l Executive DirectorBiosimilars are the Future of Affordable Medicines,but Face Serious HeadwindsEven as the generic drug market exhibits increasing fragility,biosimilar medicines continue to demonstrate their promise of lower costs and greater access for patients,while struggling to fulfill their p

11、otential in the face of brand biologic rebate and patent schemes.The good news:the biosimilars market continues to grow.In 2023,savings from the use of biosimilars increased by more than 30 percent,to$12.4 billion.Since their introduction,biosimilars have generated$36 billion in savings.Biosimilars

12、are demonstrating their safety and effectiveness,with more than 2.7 billion days of patient therapy with no meaningful differences in clinical outcomes.Moreover,biosimilars are increasing patient access to care495 million more days of patient therapy have occurred because of biosimilar competition.D

13、espite these positive trends,the biosimilars market faces severe challenges to long-term sustainability.While a few biosimilar products show higher utilization rates,overall,biosimilars achieved only a third of the market versus brand biologics in 2023.Last year we witnessed the PBM challenge facing

14、 new biosimilars,as biosimilar versions of best-selling biologic Humira combined to achieve less than two percent of the market despite offering price discounts of greater than 80 percent.There are still improvements to be made to develop a robust marketplace that supports multiple biosimilar compet

15、itors and avoids the“race to the bottom”pricing that has driven generic drug shortages.On top of that,the government price-setting provisions in the Inflation Reduction Act have introduced an additional layer of complexity that manufacturers must navigate when considering future biosimilar developme

16、nt.These challenges to biosimilar adoption,combined with the cost of development,are why more than 80 percent of brand biologics that are eligible for competition do not have biosimilars in development.This should serve as a wakeup call to policymakers.Without rapid action to streamline the FDA appr

17、oval process,reduce abusive patent thickets,mitigate the unintended consequences of government price-setting,and remove the perverse incentives of PBM and brand drug rebates,patients will not realize the full value of biosimilars.Biosimilars have already provided more life-saving medications to more

18、 patients,but more savings and access are possible.This depends on swift legislative and regulatory actions to establish a competitive and sustainable biosimilars market for future generations.Craig Burton Executive Director,Biosimilars CouncilINTRODUCTION4AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SA

19、VINGS REPORT 2024About the Association for Accessible Medicines&the Biosimilars Council zThe Association for Accessible Medicines(AAM)is the nations trade association for manufacturers of generic and biosimilar prescription medicines.AAMs core mission is to improve the lives of patients by advancing

20、 timely access to affordable,FDA-approved generic and biosimilar medicines.zAAM members are manufacturers of finished generic and biosimilar pharmaceutical products,manufacturers of bulk active pharmaceutical chemicals,and suppliers of other goods and services to the generic and biosimilar pharmaceu

21、tical industry.zThe Biosimilars Council,a division of AAM,works to create a positive regulatory,reimbursement,and policy environment to expand patient access to and encourage the utilization of biosimilar medicines.zAAM and its Biosimilars Council work to expand patient access to safe,quality,and ef

22、fective generic and biosimilar medicines by educating stakeholders and advancing policies that enable our manufacturers to deliver these medicines to patients.INTRODUCTION5AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024I.IntroductionII.Overall Savings Generated by Generics and Biosimila

23、rsIII.Savings By CategoryIV.Patient Out of Pocket CostsV.New Generic SavingsVI.Drug ShortagesVII.BiosimilarsVIII.ConclusionIX.MethodologyX.EndnotesXI.Contact Us26121720242736373940The U.S.Generic&Biosimilar Medicines Savings ReportS E P T E M B E R 2 0 2 4TABLE OF CONTENTS6AAM|THE U.S.GENERIC&BIOSIM

24、ILAR MEDICINES SAVINGS REPORT 2024Overall Savings Generated by Generics and Biosimilars7AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Topline FindingsOVERALL SAVINGS GENERATED BY GENERICS AND BIOSIMILARS zTotal generic and biosimilar savings in 2023:$445 billion zTotal generic and bios

25、imilar savings for the past ten years:$3.1 trillion zTotal generic and biosimilar savings in Medicare in 2023:$137 billion($2,672 per beneficiary)zTotal generic and biosimilar savings in the commercial market in 2023:$206 billion zShare of total U.S.prescriptions filled:90 percent zShare of total U.

26、S.prescription drug spending:13.1 percent zShare of total U.S.healthcare spending:1.2 percentTotal Savings from Biosimilars zSavings in 2023:$12.4 billion zTotal savings since first biosimilar entry in 2015:$36 billion zTotal days of patient therapy since 2015:2.7 billion zIncremental days of patien

27、t therapy that would not have occurred without biosimilar competition:495 millionDrug Shortages zPercentage of shortages affecting generics:84 zPercentage of shortages related to sterile injectables:67 zPercentage of shortages for drugs priced at$1/unit or less:56Total Savings from Generics and Bios

28、imilars8AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Savings From Generics and Biosimilars Totaled$445 Billion in 2023 Generic and Biosimilar Savings Increased by$37 Billion zGeneric drugs contain the same active ingredients at the same strength and purity as their brand counterparts

29、but are priced at a fraction of the cost.zBiosimilars are lower-cost versions of expensive biologic medicines.They are approved by the Food and Drug Administration(FDA)as highly similar to,and with no clinically meaningful differences from,an existing FDA-approved biologic.zBecause of their lower co

30、sts,generics and biosimilars represent more than 90 percent of the prescriptions dispensed in the U.S.zAnnual savings from generics and biosimilars exceeded$445 billion in 2023,more than$12 billion of which comes from biosimilar medicines.OVERALL SAVINGS GENERATED BY GENERICS AND BIOSIMILARS9AAM|THE

31、 U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Biosimilars Are Delivering Savings and Expanding Patient Access Biosimilars Are Also Driving Brand Prices Down zThe biosimilar market is rapidly growing,with 57 approved biosimilars for 17 reference biologics.Forty-one biosimilars are now availabl

32、e to patients.zBiosimilars have been used in 2.7 billion days of patient therapy with no clinically meaningful differences in safety or efficacy.zPatients have received 495 million more days of therapy than if no biosimilar was available.Put simply,biosimilars are making it possible for more patient

33、s to receive care.zRobust biosimilar price competition results in lower prices today more than 40 percent lower than the brand biologic price at the time of biosimilar launch.zBiosimilar competition also lower prices on brand biologics by more than one-third lower since biosimilar market entry.zBut

34、more remains to be done.Biosimilar adoption has been slower than anticipated due to brand biologic rebate barriers,and the majority of brand biologics do not have a biosimilar in development.zPolicymakers must reduce the cost of development and ensure more rapid adoption of lower-price biosimilars.O

35、VERALL SAVINGS GENERATED BY GENERICS AND BIOSIMILARS10AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Generics and Biosimilars Are More Than 90 Percent of All Prescriptions but Only 13 Percent of Spending Generic Prices Have Fallen 20 Percent Since 20191 zIn 2023,generics and biosimilars

36、 continued to demonstrate their value proposition representing 90 percent of all prescriptions but only 13.1 percent of prescription drug spending.2 zGeneric and biosimilar medicines are the only segment of healthcare that consistently deliver lower costs.zIn 2023,the average out-of-pocket cost for

37、a generic was$7.05,while the average out-of-pocket cost for a brand drug was nearly four times higher at$27.10.3 zIn fact,generic prices continue to experience severe deflation;the overall value of all generic sales in the U.S.has declined by$6.4 billion since 2019 despite increased volume and new g

38、eneric launches.2,4OVERALL SAVINGS GENERATED BY GENERICS AND BIOSIMILARS11AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Generics and Biosimilars Account for Less Than 2 Percent of Total U.S.Spending on HealthcareGeneric and Biosimilar Medicines Provide Patient Access to High-Value Care

39、 zAlthough patients receive a generic or biosimilar 90 percent of the time,these lower cost medications are less than two of every 100 dollars spent on healthcare in the U.S.zThe U.S.healthcare system has saved nearly$3.1 trillion in the last 10 years due to the availability of affordable generic an

40、d biosimilar medicines.In 2023,competition from generics and biosimilars resulted in more than$445 billion in savings to the healthcare system,including more than$137 billion in savings for Medicare.zThis continues a years-long trend of generic price deflation.In fact,the share of spending attributa

41、ble to brand drugs continues to increase even as the total number of prescriptions filled by brand drugs has declined by half in the past 10 years.2,5OVERALL SAVINGS GENERATED BY GENERICS AND BIOSIMILARS12AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Savings by Category13AAM|THE U.S.GE

42、NERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Top 10 Products by Volume,2023ProductsGeneric Entry YearBrand Pre-Expiry Price (Per Unit)Price of Generic Equivalent 2023 (Per Unit)2023 Savings($Bn)Percent Savings2023 Volume Units Dispensed(Mn)Glucophage2021$0.66$0.04$5.694%9910Neurontin2023$1.02$0.06$

43、7.595%7736Lipitor2010$3.29$0.08$24.897%7736Toprol XI1993$0.41$0.06$2.186%5872Norvasc2006$1.54$0.02$8.499%5544Zestril1998$0.67$0.03$3.296%4920Amoxil1993$0.04$0.04$0.05%4399Cozaar2009$1.51$0.07$6.196%4237Prilosec2001$3.31$0.05$12.198%4094Crestor2015$5.78$0.08$19.0799%3467The 10 Most Dispensed Generics

44、 of 2023 Saved$89.5 BillionThe Top 10 Generics by Volume Represent 20 Percent of Savings in the Past 10 Years zGeneric competition continues to generate billions of dollars in savings each year.This years data highlights the larger impact of generics for Amoxil and Crestor.zGenerics provide savings

45、through new launches,through widely-used medicines for chronic conditions,and through generics used in low-volume markets.zThe 10 most commonly prescribed generic medicines accounted for$89.5 billion in savings in 2023.These medicines provide care for patients with the most prevalent chronic health

46、conditions.zThe 10 generics with the highest total savings achieved$127 billion in savings in 2023(28 percent of total generic savings).SAVINGS BY CATEGORY14AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Savings by ConditionConditionTotal Savings(Primary Condition+Comorbidities)Heart Di

47、sease$118.1 billionMental Illness$76.4 billionDiabetes$61 billionCancers$25.5 billionAllergies&Asthma$13 billionArthritis$5.6 billionMultiple Sclerosis$4.6 billionCrohns&Colitis$2.4 billionBone Disease(Osteoporosis,Osteoarthritis,etc.)$2.2 billionAutoimmune Diseases$350 millionGenerics And Biosimila

48、rs Save Billions for PatientsGeneric and Biosimilar Medicines Provide Significant Relief for Patients With Chronic and Acute Conditions Alike zTo better understand the value of generic drugs,one can examine the savings by some of the most common patient conditions and comorbidities.zFor example,in 2

49、023,patients were protected from higher prescription medicine costs for:Heart Disease:Generics saved patients$118.1 billion.Mental Health:Generics saved patients with anxiety and depression almost$76.4 billion.Cancers:Generics and biosimilars saved patients$25.5 billion.zThese savings are found both

50、 in treatment for the underlying condition as well as in treatments for some of the most common comorbidities of each of these conditions.zBiosimilars promise additional savings for complex conditions,such as cancer and autoimmune diseases.Just as generics offer savings over brand-name drugs,these s

51、afe,effective alternative versions of biologic medicines promise to improve the quality of life for Americas patients,while at the same time saving the health system billions of dollars.SAVINGS BY CATEGORY15AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Savings by State Patients Across

52、the U.S.Can Find Relief From Prescription Drug Costs Through Generics and Biosimilars zEncouraging use of lower-cost generic and biosimilar medicines is a way for employers and states to ensure access and manage spending for states with patients diagnosed with chronic and complex conditions.zOn aver

53、age,the use of generics and biosimilars saved more than$8 billion per state in 2023,with savings ranging from approximately$600 million(Alaska)to nearly$38 billion(California).zBecause more populous states often experience higher healthcare costs,such states also often realize greater savings throug

54、h the use of generic and biosimilar medications.SAVINGS BY CATEGORY16AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Generic and Biosimilar Savings Benefit Commercial Insurance and MedicareUse of Generics and Biosimilars in Medicare Saved$137 Billion in 2023Generics and biosimilars provi

55、de critical savings throughout the healthcare system and are particularly valuable to Medicare and employer-sponsored health insurance and the patients they serve.zIn 2023,the use of generics and biosimilars saved:$137 billion in Medicare;and$206 billion in commercial health insurance.zRegardless of

56、 changing beneficiary dynamics due to an aging population and plan eligibility or enrollment policies,generics and biosimilars offer sustained cost relief.zMedicines taken by older adults account for the majority(78 percent)of total savings:Adults aged 40-64 accounted for$194 billion in savings.Seni

57、ors over age 65 accounted for$151 billion in savings.zBut many patients are being denied access to new generics and biosimilars or are forced to pay too much for their generic prescription.In fact,almost two-thirds of all Medicare beneficiaries were forced to pay the full cost for at least one gener

58、ic in 2021.6 This is why patients increasingly resort to paying cash for their medicines.7SAVINGS BY CATEGORY17AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Patient Out-of-Pocket Costs 18AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Nearly 60 Percent of Generic Drugs in M

59、edicare Are Not on Generic Tiers Plans Shift Generics Onto Higher Tiers and Increase Patient Costs zMany patients face unnecessarily high costs due to PBM and health plan formulary decisions that place generics on non-generic tiers.zFormulary tiers are intended to reward patients when they use the l

60、owest-cost option possible.In recent years,as prices for generic medicines continue to fall,many Medicare Part D plans continue to place generics on higher tiers with higher copays.This forces seniors to pay more for lower-cost generic medications,often more than the cost of the medication.zThe resu

61、lt is that patients are paying more for their generics even as those generic prices have declined.6 zThis drives up patient spending on the lowest-priced medicines,and forces many insured patients to abandon their insurance and instead pay cash using pharmacy discount cards to afford their generic m

62、edicine.7PATIENT OUT-OF-POCKET COSTS19AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Patients Overpay for Generics Due to Improper Formulary Placement Patients Are Paying More Even As Generic Prices Are Going Down zDecisions by PBMs and health plans to shift generics to non-generic tier

63、s increases copays and imposes higher costs on patients.zAn analysis of generic drugs covered from 2011 to 2019 found that shifting generics to brand tiers resulted in a 135 percent increase in annual patient spending,even as the average price of those medicines fell by 38 percent.8 zThe number of p

64、atients forced to pay the full cost of the drug is growing.zIn 2017,45 percent of patients in Medicare paid the full cost of their generic at least once.But by 2020,almost two-thirds of Medicare patients bore the full cost of their generic medicine.8PATIENT OUT-OF-POCKET COSTS20AAM|THE U.S.GENERIC&B

65、IOSIMILAR MEDICINES SAVINGS REPORT 2024New Generic Savings21AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024New Generics and Biosimilars Bring Lower Prices But Many Patients Lack AccessNew Generics and Biosimilars Generated$131 Billion in Savings in 2023 zBrand drug manufacturers enjoy y

66、ears of regulatory exclusivity prior to a generic or biosimilar companys ability to enter the market.During this time,patients often experience repeated price increases.zNew generics and biosimilars generate lower costs and greater access to care for patients.zBiosimilars and first generics come to

67、market as a result of successful patent challenges,settlement agreements permitting earlier entry,or patent expiry.zHowever,greater savings are being stymied by patent thickets and PBM rebate practices.Increasingly,new generics and biosimilars face challenges to delays in health plan coverage.For in

68、stance:Biosimilars continue to face challenges to adoption.New generics were only dispensed 75 percent of the time in 2023.NEW GENERIC SAVINGS22AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Medicare Plans Are Particularly Slow to Cover New GenericsLaunch year201620172018201920202021202

69、2MCMCMCMCMCMCMC201622%46%31%68%63%72%58%72%60%76%62%78%61%90%201712%58%25%73%58%73%65%76%65%76%64%89%201817%39%27%49%51%59%54%60%54%84%201931%44%59%60%72%61%72%88%202021%55%41%66%60%90%202123%86%46%89%Medicare Part D(M)Commercial(C)New Generics Face Delays in CoverageMany PBMs and Health Plans Delay

70、 Coverage of New Lower-Cost Generics zSlower adoption and lower efficiency rates for new generics is driven in part by slower coverage decisions by PBMs and health plans.These entities benefit from rebates on high-priced brand drugs,even though patients would save through lower-cost generics or bios

71、imilars.zFor instance,it appears to take roughly three years before new generics are covered by more than half of all Medicare drug plans.During this time,lack of coverage restricts patient access to lower-cost generics.9 zThis means that pharmacies cannot provide a patient with a lower-cost generic

72、 if the plan formulary blocks it in favor of the higher-priced brand with high rebates.zAlthough an average of 50 percent or more of commercial plans typically cover first generics the year after launch,this coverage appears to plateau over time.zAlthough the Inflation Reduction Act included changes

73、 to Medicare that may encourage plans to cover new generics,it retained the perverse incentives for PBMs to prefer high-priced brand drugs that provide high rebates and fees.NEW GENERIC SAVINGS23AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024New Generic Market Adoption Has SlowedHigh Pr

74、ices and Rebates Allow Brand Drugs to Retain Market Share Against Lower Net Priced Generics zWhile nearly half of the small molecule generics reached over 75 percent market share by the end of 12 months,that is less than in prior years.This is in large part due to the recent trend of PBMs preferring

75、 brand drugs with high list prices,even when the generic or biosimilar would cost less for patients.zFor instance,the entry of biosimilar versions of insulin and Humira boasting discounts of more than 80 percent has been stymied by PBM decisions to continue preferred coverage of the higher-priced br

76、and.zFurther,two class action lawsuits recently filed by employees of two large corporations allege PBM formulary practices caused employees to overpay for prescription drugs.And a whistleblower lawsuit describes how a major vertically-integrated PBM blocked coverage of new generics and ensured that

77、 its in-house pharmacies did not purchase the generic.zSuch practices and incentives favoring higher-cost brand drugs are a significant barrier to the sustainability of low-priced generic and biosimilar competition.NEW GENERIC SAVINGS24AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Drug

78、 Shortages25AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Drug Shortages Continue to Hamper Patient Care Generic Drug Shortages Are a Symptom of Challenges Facing Generic Sustainability zAlthough drug shortages affect both brand and generic drugs,generic drugs may be at greater risk of

79、 shortages.zThe increase in generic drug shortages is closely correlated with unsustainably low prices,new government policies that harm generic competition,supply chain challenges,as well as regulatory and manufacturing challenges.zIn fact,more than 6 of 10 generic drugs that are in shortage have a

80、 price of$1 per unit or less.zReducing future drug shortages requires a comprehensive set of policies to improve the long-term sustainability of generic drug competition through earlier adoption of new generics,ending abusive purchasing practices,preventing a race-to-the-bottom in prices,and reformi

81、ng government policies that penalize low-cost generic manufacturing.DRUG SHORTAGES26AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024 zWhile each drug shortage is unique,a common thread among shortages is unsustainably low generic prices further exacerbated by new government policies that

82、 undermine competition.zThe result can strain supply chains and leave providers without sufficient supply for patients.zPolicymakers can reduce future shortages by creating incentives for earlier adoption and more sustainable pricing of generic medicines.zAs FDA Commissioner Dr.Robert Califf recentl

83、y noted,“We have got to fix the core economics if were going to get this situation fixed.”10DRUG SHORTAGESShortages Are More Common for Lower-Priced Drug Products 60%of Generic Molecules in Shortage Are Priced Less Than$1.00 per Unit27AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Biosi

84、milars28AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024The U.S.Biosimilars Market The Biosimilars Landscape Is Growing zTo date,the FDA has approved 57 biosimilars across 17 molecules.zForty-one biosimilars are on the market with prices averaging more than 40 percent less than the refer

85、ence brand biologic price at launch.11 zAlthough there are currently 97 biosimilar development programs underway,there are nonetheless too many potential biosimilars that are not being developed.11 In fact,86 percent of brand biologics that are eligible for biosimilar competition do not have a biosi

86、milar under development.12 This is a reflection of the cost of development and the uncertainty regarding the future of the biosimilar market in the United States.zTo date,the bulk of biosimilar competition involved products that are directly purchased and administered by healthcare providers(medical

87、 benefit or buy-and-bill).zNew biosimilar launches in insulin and adalimumab represent the first entry of pharmacy-dispensed biosimilars,although PBM adoption has been slower than hoped.BIOSIMILARSMedical Benefit BiosimilarsPrescription Benefit BiosimilarsAs of November 202429AAM|THE U.S.GENERIC&BIO

88、SIMILAR MEDICINES SAVINGS REPORT 2024Biosimilars Have Generated$36 Billion in Savings Since 2015 Savings Reflect Provider Confidence and Robust Price CompetitionBIOSIMILARS zSince the first biosimilar launch in 2015,patients and the healthcare system have saved nearly$36 billion.zSavings are increas

89、ing as biosimilar adoption has grown.Sixty percent of total savings from biosimilar entrants has occurred in the past two years,with over$12.4 billion in savings in 2023 alone.zHowever,biosimilar adoption continues to trail expectations because of misaligned incentives and PBM practices that slow ad

90、option.zAlthough biosimilar adoption has been higher among medical benefit biosimilars,it remains too low in many instances.And even markets with robust biosimilar adoption remain unable to support multiple competitors.zAdoption of pharmacy-dispensed biosimilars such as insulin and biosimilar Humira

91、 remains disappointing due to PBM formulary practices favoring high-priced brand biologics with high rebates and fees that benefit the PBM but that are not shared with patients.30AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Biosimilars are Delivering Safe TherapyBiosimilar Introductio

92、n Often Results in Greater Patient Access zThe increasing use of biosimilars should put to rest any questions about their safety and efficacy.zSince 2015,biosimilars have been used in almost 2.7 billion days of patient therapy with no meaningful differences in safety or clinical outcomes.zMoreover,o

93、verall use of molecules with biosimilar competition has increased.This means that more patients use medicines when a biosimilar is available.zFor instance,over 25 percent more doses of pegfilgrastim,used to generate new white blood cells for patients fighting cancer,have been dispensed since its bio

94、similar entered the market.zIn fact,biosimilar competition has now supported more than 495 million incremental days of therapycare that patients would not have received otherwise.BIOSIMILARS31AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Although Improving,Biosimilar Adoption Remains T

95、oo SlowBiosimilar Adoption Is Hindered by Incentives for Using Costly Brands zThe biosimilar efficiency rate,the rate at which biosimilars are dispensed when available,is growing but remains too low.zWhile biosimilars are 80 percent or more of the market in two therapeutic areas,the average market s

96、hare for all biosimilars remains under 20 percent.zEven where biosimilars have been adopted,the majority of the market share is concentrated among one or two competitors.The market is not yet supporting multiple biosimilars within a molecule,leading to a winner-takes-all dynamic that could dampen fu

97、ture development.zA sustainable biosimilars market is one that supports rapid adoption by multiple competitors.BIOSIMILARS32AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Biosimilars Launch at a Discount and Continue to Decrease Their PricesBiosimilars Also Drive Down Brand Prices zPrio

98、r to biosimilar entry,brand biologics take significant price increases.After biosimilar entry,brand prices tend to go down.13,14 zBrand biologics have reduced by 33 percent on average.This results in savings from both the originator biologic and biosimilars.13 zToday,biosimilars,on average,are price

99、d more than 40 percent lower than the brand biologics price at the time of biosimilar launch.13 zProperly aligning incentives to support biosimilar adoption could save as much as$42.9 billion in medical costs by 2027.15BIOSIMILARS zHowever,the long-term sustainability of the biosimilars industry is

100、in doubt,given the costs of development,the slow adoption by health plans and PBMs,and the uncertainty created by the government price setting approach established in the Inflation Reduction Act.zAchieving the full promise of lower-cost biosimilars requires streamlining the development and approval

101、process,removing the patent thickets that delay market introduction,and aligning coverage and reimbursement policies to encourage use of these lower-cost medicines.Biosimilars Consistenly Drive Down Costs33AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Biosimilars Adoption Remains Too S

102、lowBiosimilars Face Obstacles to Adoption zAlthough they face challenges,small molecule generics fare better than biosimilars in gaining market share when brand product loses exclusivity.First generics launched in 2021 and 2022 typically achieved 47 percent of the market share within one year of the

103、 loss of exclusivity.zAmong biosimilars,there is wide variation in market share,with the average around 20 percent at one year.zAdoption of adalimumab biosimilars has been particularly lowat one percent,due to insurer coverage decisions that fail to prioritize lower-cost treatments for patients.BIOS

104、IMILARS34AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Maintaining Patients on Humira Comes at a Cost of Up to$6 Billion per Year for Patients and EmployersMany PBMs and Health Plans Continued Use of Brand Humira Instead of Biosimilars With Lower Net Costs zPBM rebates and fees tied to

105、 high brand list prices continues to maintain a stranglehold on coverage decisions,to the detriment of patients.Despite price discounts of greater than 80 percent,adoption of biosimilar versions of Humira has been disappointingly slow,achieving less than two percent market share in their first year

106、on the market.zEven when rebates are taken into account,biosimilar options have lower net costs for employers and patients.zIQVIA found that adalimumab biosimilars offer up to$6 billion in potential savings;however,switching all U.S.patients would lead to an estimated 84 percent decrease in PBM prof

107、its.zThis is a result of:Continued PBM reliance on rebates and fees that are tied to brand drug high list prices;and PBM practice of rewarding their vertically-integrated in-house specialty pharmacy networks compared to independent specialty and retail pharmacies.zThe vast majority of biosimilar Hum

108、ira adoption in 2023 was by PBMs that are not reliant on rebate revenue and that prioritize use of lower-priced medicines.BIOSIMILARS35AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Co-Branded Hyrimoz is Driving Increased Biosimilar UtilizationLarge PBMs Continue To Favor Humira or Co-b

109、randed OptionsProduct Hopping Outpaces BiosimilarsPBMs Continue to Play a Large Role in Patient Access to BiosimilarsPBM Strategies Product Hopping Are Suppressing Uptake of Lower-Cost BiosimilarsMany PBMs and Health Plans Continued Use of Brand Humira Instead of Biosimilars With Lower Net Costs zDe

110、spite price discounts of greater than 80 percent,biosimilar adoption has been disappointingly slow.zIn their first year on the market,biosimilars achieved less than two percent of total market share,primarily through adoption by non-rebate dependent,smaller PBMs.zAdoption increased in the spring of

111、2024 when a major vertically integrated PBM adopted and began driving use of a biosimilar.zNonetheless,large PBMs continue to prefer the high-priced brand over biosimilars.zIn fact,the major PBMs have partnered with the brand company to shift more patients to newer high-priced brands than to biosimi

112、lars.zAs a result,the brand manufacturers immunology portfolio,consisting of three products,currently outnumbers all adalimumab biosimilar dispensing by a factor of 24 to 1.BIOSIMILARS36AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024ConclusionGeneric medicines continue to provide value

113、to patients,taxpayers,employers,and the healthcare system.And biosimilars are increasingly delivering on their promise of lower prices and expanded access for patients.Generic and biosimilar medicines serve patients,ensuring that each one receives the medicine they need,when they need it.Moreover,th

114、ey are expanding patient access,making life-savings medicines more affordable for patients,enabling patients to better adhere to their therapies,and ultimately saving lives.But the continued savings achieved through use of lower-cost generics and biosimilars can no longer be taken for granted.The lo

115、ng-term outlook for generic and biosimilar competition hinges on addressing the barriers to development and adoption and,ultimately,sustainability of this vital industry.Without action to strengthen the generic and biosimilars markets,many of these lower-cost medicines may disappear,and patients acc

116、ess to care will suffer.CONCLUSION37AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024MethodologyThe value of generics currently on the market was estimated using the pre-expiry prices of the brands they replaced.The current dataset includes pre-expiry brand prices for 1,302 generic molecu

117、les.The value of each generic molecule was determined by multiplying its pre-expiry brand price by the generic volume sold in each of the last ten years.This value represents what would have been spent on brand medicines in the absence of generic competition.The savings attributed to each of the 1,3

118、02 generic molecules was determined by subtracting historic generic spending from the estimated brand spending in the absence of generic competition.This analysis was refreshed with annual sales and volume data for all medicines sold in the United States between 1993 and 2023,focusing on the 10-year

119、 savings for the period 2014 to 2023.Savings from generics launched in the 1994 to 2023 study period are based on the most current knowledge of their pre-expiry prices.Generic savings were calculated at the molecule-class level using a single average price for each molecule across all formulations(o

120、ral solid,liquid).Molecules that are available in multiple formulations are assumed to have the same pre-and post-expiry utilization patterns.Molecules with injectable formulations were calculated related to specific formulations to appropriately measure the cost differences between brands and equiv

121、alent generic forms.State level generic savings was estimated by apportioning total savings for each molecule by each states share of the national retail prescription volume.This method embeds two assumptions:first,that prices are uniform across the country,and second,that retail prescription activi

122、ty mirrors prescription activity in other channels,notably mail order.Savings generated by children,young adults,older adults,and seniors were estimated based on national prescription trends captured in the IQVIA New to Brand Audit.These figures represent the portion of the national savings generate

123、d by each age group,not the sum of the patients personal savings.Savings by pay type were estimated using the share of each molecule dispensed via retail pharmacies to patients paying with cash and those covered by Medicare,Medicaid,and commercial insurance.After calculating savings at the molecule,

124、state,and payer level,results were summed to the state-payer level.This method does not analyze the cost to the patient who may have a copay or discount card;rather it divides generic savings equally amongst patients based on prescription use,regardless of insurance plan.Patients with Medicaid,Medic

125、are,and commercial insurance pay different prices for their medications based on their insurance benefit design.This analysis did not attempt to estimate savings to individual patients based on their method of payment.Instead,total generic savings for each molecule was divided evenly based on the nu

126、mber of prescriptions filled by patients of each pay type.In previous editions of this study,the IQVIA Institute has employed not previously available historic archives.The prior versions of this study were based on archives and live data covering periods 2004-present.The current edition of the stud

127、y includes archives extending a further 12 years to 1992.The calculation of generic savings depends upon the brands pre-expiry price,or METHODOLOGY38AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024the oldest available brand price if the pre-expiry price is not available.Older generics,pa

128、rticularly those first launched 1992-2004,and even those first launched before 1992,now have improved accuracy in the study.Brand prices change post-expiry,and therefore the more complete and accurate prices have improved the accuracy of the savings estimated in the study.In the study released in 20

129、24,molecules with 25 percent of prescriptions flowing through a single method of payment in a single state were excluded.These molecules are generally non-retail but may flow through unusual channels in specific states,potentially skewing savings data.Sixty unique molecules were excluded from state

130、and method of payment calculations.The average share of TRx for non-excluded molecules in the largest states is only one percent.Generic and brand drug share of prescription drug spending was calculated using an analysis of CMS National Health Expenditure data and IQVIA National Sales Perspective da

131、ta.Total drug spending was segmented into generics and brands.Those percentages were then applied to the National Health Expenditure estimates of spending by type of expenditure within the CMS data.This report estimates condition level savings from generics as a single year estimate for 2023.The bas

132、e savings were calculated by IQVIA.Avalere generated condition-level savings by assigning drugs to a list of common conditions.Avalere then aggregated savings for all drugs that are used to treat these conditions.Importantly,many products treat multiple conditions.For purposes of this analysis,Avale

133、re relied on internal subject matter expertise to determine the primary use of the product when assigning it to a condition.Avalere calculated comorbidity savings estimates for the three most common comorbidities for each of the index conditions and based on publicly available epidemiology data.Aval

134、ere calculated the base savings for the primary condition in the same manner as described above,and then assigned a weighted savings to each of the three selected comorbid conditions based on published prevalence data.Because the IQVIA data offers units rather than patients,Avalere used units as a p

135、roxy for the number of patients treated and adjusted the units,and thus savings,in proportion to the published prevalence of each comorbid condition.This methodology,due to the differences in units utilized by patients for specific conditions,could lead to estimates of comorbidity savings that excee

136、d the total savings for that stand-alone condition.In these cases,the comorbidity savings were capped at the savings for that stand-alone condition to ensure a lower savings estimate.METHODOLOGY39AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Endnotes1 Long,D.(February 2024).US Generics

137、&Biosimilars Trends,Issues&Outlook,IQVIA.2 IQVIA Contributors.(May 2023).The Use of Medicines in the U.S.2023.https:/ IQVIA Contributors.(May 2024).The Use of Medicines in the U.S.2024:Usage and Spending Trends and Outlook to 2028.https:/ Long,D.(August 2023).US Pharmaceutical Trends,Issues and Outl

138、ook,IQVIA.5 Fiore JA,Madison AJ et al.(June 2024).National Health Expenditure Projections,202332:Payer Trends Diverge As Pandemic-Related Policies Fade.Health Affairs.https:/www.healthaffairs.org/doi/full/10.1377/hlthaff.2024.004696 Avalere Health Contributors.(July 2022).Some Medicare Part D Benefi

139、ciaries Pay Full Price for Generic Drugs.https:/ Association for Accessible Medicines Contributors.(October 2022).The U.S.Generics and Biosimilar Medicines Savings Report.https:/accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf8 Association for A

140、ccessible Medicines Contributors.(October 2022).Patients Pay More When Generic Drugs Are Placed On Non-Generic Tiers,Even Though Prices for Generics Are Going Down.https:/accessiblemeds.org/resources/blog/patients-pay-more-when-generic-drugs-are-placed-non-generic-tiers9 Association for Accessible M

141、edicines Contributors.(January 2023).Middlemen Increasingly Block Patient Access to New Generics.https:/accessiblemeds.org/sites/default/files/2023-01/AAM-Middlemen-Block-Patient-Access-New-Generics-2023.pdf10 Kansteiner,Fraiser.(August 2023).A tale of 2 industries:FDAs Robert Califf weighs in on fu

142、ndamental problem causing so many shortages.Fierce Pharma.https:/ U.S.Food&Drug Administration Contributors.(August 2023).Biosimilars.https:/www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars12 IQVIA Contributors.(January 2023).Biosimilars in the United States 20232027.https:/ Cent

143、ers for Medicare&Medicaid Services Contributors.(July 2023).ASP Pricing Files.https:/www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files14 MEDPAC Contributors.(June 2023).Addressing high prices of drugs covered under Medicare Part B.Report to the Congress:Medicare and the Health Care Deliver

144、y System.https:/www.medpac.gov/wp-content/uploads/2023/06/Jun23_Ch1_MedPAC_Report_To_Congress_SEC.pdf15 PWC Contributors.(2024).Medical Cost Trend:Behind the Numbers 2025.https:/ REFERENCES40AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024Association for Accessible Medicines601 New Jerse

145、y Ave NWSuite 850Washington,D.C.20001202-249-7100accessiblemeds.orgFollow AAM on social media /accessiblemedsContact UsBiosimilars CouncilA division of the Association for Accessible Medicinesbiosimilarscouncil.orgFollow the Council on social media /biosimscouncilCONTACT US41AAM|THE U.S.GENERIC&BIOSIMILAR MEDICINES SAVINGS REPORT 2024accessiblemeds.orgbiosimilarscouncil.org