1、Unveiling the Potential of Biosimilars:Past Achievements and Future P2ContentsIntroduction3Biosimilars versus generics3Advantages of biosimilars3Global distribution of biosimilars approvals(5 years)4The first biosimilar9Change in regulatory guidelines for the approval process10Interchangeable biosim

2、ilars10Sales analysis of reference biologic post biosimilar launch(2019-2023)11Comparative account of Year-Over-Year sales of reference products16Global distribution of launched biosimilars18Key players in the market for launched biosimilars19The next wave of biosimilars20Global distribution of upco

3、ming biosimilars27Key players in the upcoming market29Conclusion30References32Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects IntroductionBiosimilars are safe and effective treatment options for many illnesses,such as chronic skin and bowel diseases(like psoriasis,irrit

4、able bowel syndrome,Crohns disease,and colitis),arthritis,kidney conditions,and cancer.These medicines are very close in structure and function to biologic medicines and increase access to lifesaving medications at potentially lower costs.They are highly similar to a biologic medication already appr

5、oved by a regulatory body the original biologic(also called the reference product).Both a biosimilar and its original biologic:Are made from the same types of sources(e.g.living sources)Provide the same benefits when treating diseases or medical conditions Are provided at the same strength and dosag

6、e Are not expected to cause new or worsening side effectsBiosimilars versus genericsBiosimilars and Generics are alternate versions of medications that are already approved by a regulatory body,but these two types of medicines show some significant differences:Advantages of biosimilars Biosimilars p

7、rovide a lower-cost option to replace original-brand products Improve access to patients when compared to the reference biologics Provide more treatment options for patients with serious and life-threatening diseases Similarly effective as the reference biological medicines3BiosimilarsGenericsGenera

8、lly made from living organismsVERSUSGenerally made from chemicalsRequire a specialized processHave a simpler process to copyVery similar but not identical to original biologicCopy of brand-name drugsFaster development process using public information from original biologic approvalFaster development

9、 process using public information from brand-name drug approvalUsually less expensive than original biologicUsually less expensive than brand-name Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsGlobal distribution of biosimilars approvals(5 years)In recent years,biosimi

10、lars have gained significant attention and importance in healthcare,particularly in the United States and Europe.These biological products,which are highly similar to reference biologic medicines,offer increased access to cost-effective treatments and can potentially lower healthcare expenditures.In

11、 2019,the United States witnessed a remarkable number of biosimilars being approved,which resulted in the Food and Drug Administration(FDA)granting marketing authorization to a record-breaking number of these products(10).These FDA approvals covered various therapeutic areas,including oncology,immun

12、ology,and endocrinology.The greater availability of biosimilars in the United States is expected to enhance competition,potentially leading to reduced healthcare costs and increased patient access to critical biological treatments.The European Medicines Agency(EMA)has been involved in the approval o

13、f biosimilars in Europe since 2006.Europe has been at the forefront of biosimilar adoption,with the highest number of biosimilar approvals observed in previous years.As of 2021,the European Union has continued to see a significant number of biosimilar approvals(9),with numerous products gaining auth

14、orization for use.In the last five years the US FDA and EMA have approved 28 and 30 biosimilars respectively(Table 1 and Table 2).The highest number of biosimilars have been approved for cancer(19),followed by immunological disorders(17).4Biosimilars approved in 5 yearsFig.1:Yearly trend of biosimil

15、ars approved from 2019-2023 in US and EUTable 1:Approved biosimilars in USA(5 Years)02468101220192020202120222023Number of drugs aaprovedYearUSAEuropeNameCompany NameFDA Approval dateActemra(tocilizumab)biosimilarsTofidence(tocilizumab-bavi)Biogen Inc.29-Sep-23Avastin(bevacizumab)biosimilarsAvzivi(b

16、evacizumab-tnjn)Bio-Thera Solutions,Ltd.6-Dec-23Vegzelma(bevacizumab-adcd)Celltrion,Inc.27-Sep-22Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects 5NameCompany NameFDA Approval dateAlymsys(bevacizumab-maly)Amneal Pharmaceuticals,Inc.13-Apr-22Zirabev(bevacizumab-bvzr)Pfize

17、r Inc.27-Jun-19Enbrel(etanercept)biosimilarsEticovo(etanercept-ykro)Samsung Bioepis Co.,Ltd.25-Apr-19Herceptin(trastuzumab)biosimilarsKanjinti(trastuzumab-anns)Amgen Inc.13-Jun-19Trazimera(trastuzumab-qyyp)Pfizer Inc.11-Mar-19Ontruzant(trastuzumab-dttb)Samsung Bioepis Co.,Ltd.18-Jan-19Humira(adalimu

18、mab)biosimilarsYuflyma(adalimumab-aaty)Celltrion,Inc.23-May-23Idacio(adalimumab-aacf)Fresenius Kabi13-Dec-22Yusimry(adalimumab-aqvh)Coherus BioSciences,Inc.17-Dec-21Hulio(adalimumab-fkjp)Mylan Pharmaceuticals Inc.6-Jul-20Abrilada(adalimumab-afzb)Pfizer Inc.15-Nov-19Hadlima(adalimumab-bwwd)Samsung Bi

19、oepis Co.,Ltd.23-Jul-19Lantus(insulin glargine)biosimilarsRezvoglar(insulin glargine-aglr)Eli Lilly and Company17-Dec-21Lucentis(ranibizumab)biosimilarsCimerli(ranibizumab-eqrn)Coherus BioSciences,Inc.2-Aug-22Byooviz(ranibizumab-nuna)Samsung Bioepis Co.,Ltd.17-Sep-21Neulasta(pegfilgrastim)biosimilar

20、sStimufend(pegfilgrastim-fpgk)Fresenius Kabi USA,LLC1-Sep-22Fylnetra(pegfilgrastim-pbbk)Amneal Pharmaceuticals,Inc.26-May-22Nyvepria(pegfilgrastim-apgf)Pfizer Inc.10-Jun-20Ziextenzo(pegfilgrastim-bmez)Sandoz Inc.4-Nov-19Neupogen(filgrastim)biosimilarsReleuko(filgrastim-ayow)Kashiv BioSciences,LLC25-

21、Feb- Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects6NameCompany NameEMA Approval dateAvastin(bevacizumab)biosimilarsAbevmyMylan(now Viatris)21-Apr-21Alymsys(Bevacizumab-maly)mAbxience Research26-Mar-21AybintioSamsung Bioepis19-Aug-20OnbevziSamsung Bioepis11-Jan-21Oyava

22、s(Bevacizumab-maly)Stada Arzneimittel26-Mar-21VegzelmaCelltrion Healthcare17-Aug-22ZirabevPfizer14-Feb-19Humira(adalimumab)biosimilarsAmsparity(Adalimumab-afzb)Pfizer13-Feb-20Hukyndra(Adalimumab-EVA)Alvotech/Stada Artnimettel15-Nov-21Idacio(adalimumab-aacf)Fresenius Kabi2-Apr-19YuflymaCelltrion Heal

23、thcare11-Feb-21Libmyris(Adalimumab-EVA)Alvotech/Stada Artnimettel12-Nov-21Soliris(Eculizumab)biosimilarsBekemvAmgen24-Feb-23EpysqliSamsung Bioepis31-Mar-23NameCompany NameFDA Approval dateRemicade(infliximab)biosimilarsAvsola(infliximab-axxq)Amgen Inc.6-Dec-19Rituxan(rituximab)biosimilarsRiabni(ritu

24、ximab-arrx)Amgen Inc.17-Dec-20Ruxience(rituximab-pvvr)Pfizer Inc.23-Jul-19Stelara(ustekinumab)biosimilarsWezlana(ustekinumab-auub)Amgen Inc.31-Oct-23Tysabri(natalizumab)biosimilarsTyruko(natalizumab-sztn)Sandoz Inc.24-Aug-23Table 2:Approved biosimilars in Europe(5 Years)Unveiling the Potential of Bi

25、osimilars:Past Achievements and Future Prospects 7NameCompany NameEMA Approval dateLucentis(ranibizumab)biosimilarsByoovizSamsung Bioepis18-Aug-21Ranivisio(ranibizumab-eqrn)Bioeq/Teva Pharma25-Aug-22XimluciStada Arzneimittel/Xbrane Biopharma9-Nov-22Neulasta(pegfilgrastim)biosimilarsCegfila(previousl

26、y Pegfilgrastim Mundipharma)Mundipharma Biologics19-Dec-19GrasustekJuta Pharma(USV)20-Jun-19Nyvepria(Pegfilgrastim-apgf)Pfizer18-Nov-20Stimufend(Pegfilgrastim-fpgk)Fresenius Kabi24-Mar-22NovoRapid(insulin aspart)biosimilarsInsulin aspart SanofiSanofi-Aventis25-Jun-20Kirsty(previously Kixelle)Biocon/

27、Viatris(formerly Mylan)5-Feb-21Truvelog Mix 30Sanofi-Aventis1-Apr-22Forsteo(teriparatide)biosimilarsLivogivaTheramex Ireland27-Aug-20SondelbayAccord Healthcare24-Mar-22Enbrel(etanercept)biosimilarsNepextoMylan25-May-20Rituxan(rituximab)biosimilarsRuxience(Rituximab-pvvr)Pfizer1-Apr-20Herceptin(trast

28、uzumab)biosimilarsTrazimeraPfizer26-Jul-18ZercepacAccord Healthcare27-Jul-20Although the biosimilar pathway has seen numerous successes,the market has witnessed a few setbacks in the form of voluntary market withdrawal of some biosimilar drugs by the sponsors.For instance,Boehringer Ingelheim develo

29、ped and received marketing approval from the EMA for an adalimumab biosimilar(Cyltezo).However,the company notified the European Commission of its decision not to market the product in the EU for commercial reasons,resulting in withdrawal of the marketing authorization from the EU.Similarly,the mark

30、eting authorization for Equidacent(bevacizumab biosimilar)was withdrawn at the request of Centus Biotherapeutics.Further examples are listed in Table Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects8Product nameActive substance Market withdrawal dateCompany nameCyltezoad

31、alimumab15-Jan-19Boehringer IngelheimEquidacentbevacizumab23-Nov-21Centus BiotherapeuticsHalimatozadalimumab29-Jan-21SandozInpremziainsulin human20-Apr-23BaxterKromeyaadalimumab17-Dec-19Fresenius KabiLextemybevacizumab14-Dec-21Mylan(now Viatris)Qutavinateriparatide18-Jan-21EuroGenerics HoldingsRitem

32、viarituximab16-Aug-21CelltrionRituximab Mabionrituximab16-Mar-20MabionRituzena(previously Tuxella)rituximab10-Apr-19CelltrionSolymbicadalimumab5-Mar-19AmgenThorinaneenoxaparin sodium24-Oct-19PharmathenUdenycapegfilgrastim15-Feb-21ERA Consulting(Coherus Biosciences)Table 3:List of biosimilars volunta

33、rily withdrawn by sponsors in EuropeUnveiling the Potential of Biosimilars:Past Achievements and Future Prospects 9The first biosimilarThe EU was the first region in the world to define a policy and legal framework for the approval of biosimilar medicines.With the legal framework for biosimilars hav

34、ing been established,the EMA,together with the Committee for Medicinal Products for Human Use(CHMP),the Biotechnology Working Party,and the Working Party on Similar Biological Medicinal Products released specific guidelines to deal with all aspects of the development,production,testing,and regulatio

35、n of biosimilar medicines.Omnitrope(Sandoz)was the first biosimilar medicine to be approved and introduced on the European market.Approved in 2006 by the European Medicines Agency(EMA),Omnitrope is a biosimilar version of the previous reference medicine,Genotropin(somatropin).It is used for the trea

36、tment of growth disorders in children and adults caused by inadequate or deficient growth hormone production.To gain regulatory approval,Omnitrope underwent a rigorous development process.Extensive physicochemical and biological characterization,as well as non-clinical and clinical studies,were cond

37、ucted to demonstrate its comparability to Genotropin.These studies included assessments of pharmacokinetics,pharmacodynamics,and immunogenicity.The results showed no clinically meaningful differences between Omnitrope and Genotropin.Omnitrope and subsequent biosimilars have had the potential to revo

38、lutionize healthcare by expanding access to effective and safe biological therapies to a broader patient population.However,it is crucial to maintain robust regulatory frameworks to ensure the quality,safety,and efficacy of these biosimilar Unveiling the Potential of Biosimilars:Past Achievements an

39、d Future Prospects10Change in regulatory guidelines for the approval processOver the years,there have been several regulatory guideline changes for the approval of biosimilars.Some of the challenges faced in the old guidelines of biosimilar approval include:Lack of Regulatory Pathway:Earlier there w

40、as no specific regulatory pathway for the approval of biosimilars Complex Molecular Structure:The complexity of biosimilar manufacturing processes and structure made it challenging to establish similarity to the reference biologic Clinical Development:Conducting clinical trials to demonstrate the sa

41、fety and efficacy of biosimilars was challenging Extrapolation of Indications:Determining whether biosimilars can be extrapolated to different indications without conducting clinical trials for each specific indication was a challenge Reference Product Availability:Obtaining and accessing the refere

42、nce biologic for comparative studies was difficult,especially when the reference product was still under patent protection Interchangeability and Substitution:There were uncertainties regarding the rules and regulations for interchangeability and substitution of biosimilars with reference biologics.

43、This created challenges for healthcare providers and patients in adopting biosimilars Naming and Pharmacovigilance:The lack of a distinct naming system for biosimilars created challenges in differentiating them from reference biologics in pharmacovigilance,traceability,and adverse event reportingWit

44、h the advent of the interchangeable biosimilars,the guidelines for these products have undergone some changes.Below are a few changes:Currently,the guidelines outline the criteria and standards that biosimilar manufacturers need to meet to demonstrate interchangeability,which includes conducting add

45、itional studies to demonstrate that the biosimilar can be used interchangeably with the reference product without compromising the safety or efficacy for patients These guidelines now provide specific requirements for the labeling of interchangeable biosimilars The approval of interchangeable biosim

46、ilars has raised the possibility of automatic substitution by pharmacists without the need for specific prescriber approval(*as per the regulations and laws of individual countries or regions)Presently,robust pharmacovigilance programs are required to monitor the safety and effectiveness of intercha

47、ngeable biosimilars after launch.Interchangeable biosimilars in the USAn interchangeable product is a biological product that meets all the requirements for a biosimilar product but also meets additional requirements outlined by the Biologics Price Competition and Innovation Act.These products may b

48、e replaced at the pharmacy level without the involvement of the healthcare provider who has prescribed the reference product.To date,there are five interchangeable biosimilars approved by the US FDA.Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects 11Table 4:Interchangeab

49、le biosimilars along with their therapeutic focus.In addition to the products detailed in the above table,the following is a list of biologics which are pursuing interchangeable status,along with their involved companies:Table 5:Companies and their respective biosimilars pursuing interchangeable bio

50、similars statusSales analysis of reference biologics post biosimilar launch(2019-2023)To identify the impact the launch of a biosimilar has on the sale of its reference drug,we identified drugs that have seen one or more biosimilars launched recently and analyzed the impact of their launch on the cu

51、mulative sales of the reference drug.We identified nine drugs that recently saw the launch of related biosimilars:Rituximab,Adalimumab,Alteplase,Darbepoetin alfa,Insulin aspart,Ranibizumab,Denosumab and Tocilizumab.We compiled the sales revenue generated by the sale of the drugs from company disclos

52、ed financial reports and SEC filings.For some countries,the company had not disclosed the full sales data for 2023.Hence,our coverage stops at the last available disclosed data.The following is a short analysis of each drug:Rituximab(Rituxan)Rituximab,originally developed by Biogen,was launched as R

53、ituxan for Non-Hodgkins lymphoma in 1997.Rituximab captured a high market share due to the companys policy of actively launching the drug in other indications(such as thrombotic thrombocytopenic purpura,systemic scleroderma,pemphigus vulgaris,etc.)along with proactive expansion in the launched terri

54、tories.The first biosimilar(Truxima)became available on the market in October 2019,which did not seem to affect sales drastically in 2019.However,the launch of RUXIENCE and RIABNI in 2020 and 2021 respectively,lead to the drug demonstrating extreme downward trends.The drug registered a Year-Over-Yea

55、r(YoY)percentage sales decline of-74.40%and-64.95%in 2020 and 2021 Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsInterchangeable biosimilarReference biologicInterchangeable status approvalTherapeutic FocusSemglee(insulin glargine-yfgn)Lantus(insulin glargine)2021Diabet

56、esCyltezo(adalimumab-adbm)Humira(adalimumab)2021Autoimmune disordersCimerli(ranibizumab-eqrn)Lucentis(ranibizumab)2022Eye conditionsRezvoglar(insulin glargine-aglr)Lantus(insulin glargine)2022DiabetesWezlana(ustekinumab-auub)Stelara(ustekinumab)2023Multiple inflammatory diseasesCompanyReference biol

57、ogicBiosimilarAlvotechHumiraAVT02CelltrionHumiraYuflymaPfizerHumiraAbrilada(adalimumab-afzb)Samsung BioepisHumiraHadlima(adalimumab-bwwd)12Sales analysis of Rituximab(5 years)Sales analysis of Adalimumab(5 years)Fig 2:Sales data by year(in$USD billions)of Rituximab along with its YoY percentage chan

58、ge in revenueFig 3:Sales data by year(in$USD billions)of Adalimumab along with its YoY percentage change in revenue-0.8-0.6-0.4-0.200.20.40246810121416182020192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeAdalimumab(Raheara;Humira)Adalim

59、umab(Raheara and Humira),is a monoclonal IgG1 antibody specific for tumour necrosis factor(TNF)-alpha developed by AbbVie and AstraZeneca.It is launched worldwide for the treatment of rheumatoid arthritis,juvenile rheumatoid arthritis,psoriatic arthritis,spondylarthritis,ankylosing spondylitis,axial

60、 spondyloarthritis,plaque psoriasis,Crohns disease and ulcerative colitis.The patents on Humira expired in Europe in Oct 2018 and the first adalimumab biosimilar,Hulio(Mylan)was launched in Oct 2018.A downward trend in Humira sales in Europe were observed following the entry of biosimilars in Europe

61、 though the overall market sales were high due to high demand and absence of any Humira biosimilars in the US.Although the composition of matter patent covering Humira expired in December 2016 in the US,the non-composition of matter patents covering Humira expire no earlier than 2022.Therefore,AbbVi

62、e has made settlement agreements with Amgen and Samsung Bioepis delaying the launch of Humira biosimilars in the US until January 2023.The year-on-year sales analysis of adalimumab seems to show a downward trend which has taken sharper falls recently.Following the launch of its biosimilar drugs in t

63、he EU and rest of the world,the reference drug has experienced a significantly decreased revenue,with 2021 and 2022 reporting roughly similar amounts.The least revenue in the last five years was observed in 2023 following the launch of Humira biosimilars in the US market in 2023.-0.4-0.3-0.2-0.100.1

64、0.20.30.4051015202520192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeUnveiling the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsSales analysi

65、s of Alteplase(5 years)Fig 4:Sales data by year(in$USD billions)of Alteplase along with its YoY percentage change in revenueAlteplase(Actilyse;Activacin;Activase;Cathflo;GRTPA)Alteplase(Actilyse;Activacin;Activase;Cathflo;GRTPA)is a recombinant tissue plasminogen activator developed by Boehringer In

66、gelheim.It is launched worldwide for the treatment of catheter thrombosis,myocardial infarction,pulmonary embolism and stroke in 1988.With the prevalance of cardiovascular diseases increasing,the cost of alteplase has more than doubled over the past decade leading to a concomitant increase in its gl

67、obal revenue.The company reported a steady increase in 2023 with a revenue of$USD 2.2 billion.Though the first Alteplase biosimilar(Reveliza)was launched in 2021 in Russia,there is a high demand in the major markets like US and Europe for a more affordable alternative to alteplase.00.020.040.060.080

68、.10.121.61.71.81.922.12.22.320192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeDarbepoetin alfa(Nesp;Nespo;Aranesp)Darbepoetin alfa,developed by Kyowa Kirin and Amgen,has been available in the market for anaemia under the brand names Nesp

69、,Nespo and Aranesp.It is a long-acting erythropoiesis-stimulating glycoprotein which has half-life three-fold longer than that of Erythropoietin alfa(EPO).Its first biosimilar(Cresp)was launched in India by Dr.Reddys in 2010 followed by launch of Actorise by Hetero Drugs and Darbatitor by Torrent in

70、 China in 2014.A biosimilar was also launched in Japan by Dong ST in 2019.Subsequently,the drug has experienced a significant downward trend in global revenue in the past 5 years.Both 2022 and 2023 sales data till September demonstrated an annual sales figure of roughly$USD 1.1 billion which is a di

71、p of 29%in revenue.14Sales analysis of Insulin aspart(5 years)Fig 6:Sales data by year(in$USD billions)of Insulin aspart along with its YoY percentage change in revenueInsulin aspart(NovoLog;NovoRapid)Insulin aspart,originally developed by Novo Nordisk,has been available in the market since 1999 und

72、er the brand names NovoLog and NovoRapid for the treatment of Type-1 and 2 diabetes mellitus.The global sales of insulin aspart have shown a decreasing trend owing to the presence of many competing products for treatment and management of diabetes mellitus.The first biosimilar of Insulin aspart,Rapi

73、lin,has been available in China since 2021 followed by RinFast(GEROPHARM)in Russia and Kixelle(Biocon)in Canada in 2021 and 2023 respectively.The stiff competition is evident in the drugs annual gross revenue,with decreased earnings showing every year.In the data frame we considered,the drug had yie

74、lded$USD 2.61 billion in 2019 which has dropped to$USD 1.91 billion in 2023.-0.12-0.1-0.08-0.06-0.04-0.02000.511.522.520192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeSales analysis of Darbepoetin alfa(5 years)-0.35-0.3-0.25-0.2-0.15-0.

75、1-0.05000.20.40.60.811.21.41.61.8220192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeFig 5:Sales data by year(in$USD billions)of Darbepoetin alfa along with its YoY percentage change in revenueUnveiling the Potential of Biosimilars:Past A

76、chievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsSales analysis of Ranibizumab(5 years)Fig 7:Sales data by year(in$USD billions)of Ranibizumab along with its YoY percentage change in revenue-0.35-0.3-0.25-0.2-0.15-0.1-0.0500.050.100.511.52

77、2.533.544.520192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeRanibizumab(Lucentis;ACCENTRIX)Ranibizumab(Lucentis;ACCENTRIX)a humanized recombinant monoclonal antibody targeting vascular endothelial growth factor A(VEGF-A),was developed b

78、y Novartis and Chugai pharmaceuticals.The drug was initially launched for wet age-related macular degeneration in 2006 and later for choroidal neovascularisation,degenerative myopia,diabetic macular oedema,diabetic retinopathy,retinal oedema and retinopathy of prematurity.The first biosimilar,Ranibi

79、zumab-BS,was launched by Kidswell Bio and Senju Pharmaceutical in Japan in 2021,while BYOOVIZ was made available in the US,Canada,Germany by Samsung Bioepis in 2022.Ranibizumab biosimilars offer a promising avenue for the management of retinal diseases,especially in countries with lower socioeconomi

80、c status,where there is a lack of availability of innovator ranibizumab.The drug has faced stiff competition from multiple biosimilars launches that brought down the annual sales revenue for the drug from$USD 4 billion to$USD 2 billion,a 50%decrease in the market base,suggesting the pronounced impac

81、t the launch of the biosimilars has had on the sale of its reference drug.16Sales analysis of Denosumab(5 years)Fig 8:Sales data by year(in$USD billions)of Denosumab along with its YoY percentage change in revenueDenosumab(PRALIA;Prolia;Ranmark;Xgeva)Denosumab is a fully human monoclonal antibody th

82、at targets the receptor activator of NF-B ligand(RANKL),being developed by Amgen and marketed by various organizations across the world.The drug was launched in 2021 under the brand names PRALIA;Prolia;Ranmark and Xgeva.The first biosimilar DenosuRel was launched in India by Reliance LifeSciences in

83、 2022 and the impact of it can be seen in the sales figures of the drug.While prior to 2022 the drug was reporting a YoY increase in revenue yield,in 2023 the drug registered a decrease in sales value for the first time.However,it is to be noted here that Amgen has only disclosed the sales data for

84、the drug through the third quarter of 2023(i.e.September 2023)so the final data could provide different results.The denosumab biosimilars will enter the major markets in 2025 since patents on Prolia/Xgeva will expire in the US on 19th February 2025 and will expire in Europe on 25th June 2022,except

85、for France,Italy,Spain and the UK,where they will expire in 2025.Tocilizumab(RoActemra;Actemra)Tocilizumab is an interleukin 6(IL-6)targeting monoclonal antibody,developed by Roche for various autoimmune diseases.The drug was launched around 2009 for giant lymph node hyperplasia and in our timeline

86、analysis,the drug registered roughly$USD 1 billion in sales each year.The first biosimilar TOFIDENCE for the drug was launched in 2023 by Bio-Thera Solutions in China and,while the company registered a similar revenue from the drug as compared to 2022,with a minor decrease of-0.87%.Another tocilizum

87、ab biosimilar,Tyenne(MSB11456)was launched in 2023 by Fresenius Kabi in the European Union which has the potential to expand access to IL-6 inhibitors for patients with moderate to severe rheumatoid arthritis(RA),the FDAs approval of the tocilizumab biosimilar is a breakthrough in bringing high-qual

88、ity,affordable,and accessible autoimmune treatment options to patients and health care providers.It will be interesting to observe the sales in the upcoming year to fully understand the impact of the Tocilizumab biosimilar in the sales figure of its reference drug.-0.25-0.2-0.15-0.1-0.0500.050.10.15

89、0.2012345620192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeUnveiling the Potential of Biosimilars:Past Achievements and Future Prospects 17In summary,we can see that the launch of a biosimilar can have a profound impact on the sales of

90、its reference drug.However,major players in the market have devised multiple ways to bypass the effect of biosimilars which include geographical expansion,launching the drug in a variety of new formulations along with expansion of the therapeutic focus.The sales data for all recently-approved drugs

91、with competition from biosimilars,along with comprehensive year-on-year sales percentage data has been added below:INN nameOrganisationYear wise sales data(in$US billions)20192020202120222023Rituximab (Rituxan)Roche19.735.051.772.052.66Adalimumab(Humira)AbbVie19.215.9220.721.214.4Alteplase (Actilyse

92、,Activase)Boehringer Ingelheim/Roche1.841.92.092.12.2Darbepoetin alfa(Aranesp;Nesp;Nespo)Amgen/Kyowa Kirin1.821.731.621.151.13Insulin aspart(NovoLog;NovoRapid)Novo Nordisk 2.612.362.232.161.92Ranibizumab(Lucentis;AMD Fab)Novartis Ophthalmics/Chugai Pharmaceutical4.173.583.73.032Denosumab(Xgeva;Proli

93、a)Amgen4.694.625.265.644.52Tocilizumab(Actemra,RoActemra)Roche0.871.160.971.151.14Table 6:Annual sales of biologics with recently launched biosimilarsSales analysis of Tocilizumab(5 years)Fig 9:Sales data by year(in$USD billions)of Tocilizumab along with its YoY percentage change in revenue-0.2-0.10

94、0.10.20.30.400.20.40.60.811.220192020202120222023YoY percentage sale changeSales of drugs(in$USD billions)YearsSales per yearPercentage changeUnveiling the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsCha

95、nge in the percentage of sales for Rituximab and AdalimumabChange in the percentage of sales for Ranibizumab,Denosumab and TocilizumabFig 10A:Comparative analysis of YoY percentage change in revenue for Rituximab and AdalimumabFig 10B:Comparative analysis of YoY percentage change in revenue for Rani

96、bizumab,Denosumab and TocilizumabComparative account of Year-Over-Year sales of reference products-0.8-0.6-0.4-0.200.20.420192020202120222023Percentage of sales of drugsYearsRituximabAdalimumab-0.4-0.3-0.2-0.100.10.20.30.420192020202120222023Percentage of sales of drugsYearsRanibizumabDenosumabTocil

97、izumab19Change in the percentage of sales for Alteplase,Darbepoetin alfa and Insulin aspartGeographical distribution of launched biosimilarsFig 10C:Comparative analysis of YoY percentage change in revenue for Alteplase,Darbepoetin alfa and Insulin aspartFig.11:Geographical distribution of launched b

98、iosimilars-35.00%-30.00%-25.00%-20.00%-15.00%-10.00%-5.00%0.00%5.00%10.00%15.00%20192020202120222023AlteplaseDarbepoe?n alfaInsulin aspartGlobal distribution of launched biosimilarsThe global distribution of launched biosimilars worldwide can be quite diverse,with variations in regulatory approaches

99、,market access,and adoption rates across different regions.Detailed analysis of all the launched biosimilars revealed that India has emerged as a key player in the global biosimilar market with 81 launched biosimilars to date,due to its strong generic pharmaceutical industry,favorable regulatory env

100、ironment and affordability that has improved patient accessibility to essential treatments.This is followed by the Middle East and Latin America with 46 and 44 launched biosimilars respectively.Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of B

101、iosimilars:Past Achievements and Future ProspectsMajor players in the marketTop 3 companiesThe following image provides an overview of the top three players with their respective available biosimilars in the market:Fig 13:Top three companies with launched biosimilars Key players in the market for la

102、unched biosimilarsBiosimilars are emerging as a significant segment within the pharmaceutical industry,providing cost-effective alternatives to biologic medicines.As the demand for biosimilars continues to grow,several key players have emerged as market leaders in this sector.According to Fig.12,Rel

103、iance Life Sciences(18),Sandoz(14)and Pfizer(13)are leading the market with the highest number of launched biosimilars.Biocon(11),Intas Pharmaceuticals(10),and Zydus Cadila(10)are also prominent contributors which have improved patient access to life-changing therapies.02468101214161820Number of Mar

104、keted biosimilarsCompaniesErelziMarketedDenosuRelTrastuRelRituxiRelAdaliRelBOW015ReliBetaEtanerRelReliGrastSomatoRelChorioRelFostiRelReliFeronTenecteRelEpostimMiRelDarberelAbcixiRellNeustimReliance LifeSciencesSandozPfzerRapilinCIMERLIAvziviHalimatozRixathonPrandilinBasalinIXIFIZiextenzoErelziFilgra

105、stimHexalAbseamedOmnitropeLosminaMFENTRAVegzelmaYufymaRUXIENCEBlitzimaZIRABEVYUSIMRYHerzumaTRAZIMERAZESSLYNivestymLifmiorFig.12:Top 15 companies with launched biosimilars21Four years of sales dataFig 14:Annual sales(in$USD billions)of Insulin aspart(2020-2023)The next wave of biosimilarsIn the previ

106、ous section we analysed how biosimilars disrupt the reference drug market.Here we will explore biosimilar drugs grouped according to their therapeutic focus and we will analyze their sales in the last four years,specifically from 2020 to 2023.We identified the following main therapeutic areas:metabo

107、lic disorders,musculoskeletal disorders,autoimmune disorders,immunological disorders,supportive care,ophthalmology,bone health,and oncology,and created an in-depth analysis for each.Metabolic disordersInsulin has been one of the most explored drugs in the biosimilar market with ongoing work to launc

108、h biosimilar for Insulin aspart(NovoLog).If we analyze the sales data of the drug for the last four years,we can see that the drug has been performing decently with an average revenue of roughly$USD 2.3 billion,with the first significant dip happening in 2023 owing to fierce competition.Musculoskele

109、tal disordersTocilizumab,Ustekinumab,Golimumab,Etanercept,Secukinumab are currently launched for musculoskeletal disorders and their biosimilars are either launched in selected markets or to be launched in Major markets like US and Europe in the coming years.From the chart,we can observe a fluctuati

110、ng sales performance for each drug across the years.Tocilizumab shows a notable peak in sales in 2021,while Ustekinumab has a consistent upward trajectory,reaching its highest sales in 2023.Golimumab displays modest sales figures without significant peaks.Etanercepts sales appear to have declined ov

111、er the years,with the lowest sales recorded in 2023.Lastly,Secukinumab shows an initial increase in sales,followed by a drop in the subsequent years.These biologics are in Focus since biosimilars for tocilizumab are available in countries like China and the European Union,but not in the US where the

112、y are either awaiting launch or in late clinical development.Similarly,an ustekinumab biosimilar is launched in Canada and not in any other locations.Etanercept on the other hand has biosimilars available in many countries,yet an upcoming biosimilar SB4 has garnered interest since it is just as effe

113、ctive as the originator drug(Enbrel)in treating Australian patients with rheumatoid arthritis(RA).The introduction of biosimilars for these drugs could significantly impact their sales patterns.2.442.32.231.4800.511.522.532020202120222023Yearwise sales data(in$US billions)YearsUnveiling the Potentia

114、l of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsAutoimmune disordersAutoimmune diseases result when ones own immune system is overactive,causing it to attack and damage the bodys tissues.There are multiple drugs ava

115、ilable on the market catering to different autoimmune diseases.One of these,Natalizumab,is available for the treatment of Crohns disease and multiple sclerosis.We evaluated the drugs earnings in the last four years and we can see a significant downtrend in its revenue compared to 2020-2021.Since 202

116、2 the company has reported a 75%decline in its revenue and it may get worse as the drug receives significant competition from its upcoming biosimilar counterparts.A biosimilar of natalizumab,Tyruko,is available in Germany only and was approved in the USA in 2023.Immunological disordersAn immunologic

117、al disorder is a condition in which the immune system malfunctions leading to abnormal responses which may cause tissue damage and infections.Different allergies and hypersensitive reactions also fall under this broader therapeutic area.One candidate in this area is Omalizumab which has been approve

118、d for various allergies and hypersensitivity reactions.If we analyze the financial earnings of the drug we can see that the drug has been performing pretty decently in the last four years averaging a yield of roughly$USD 1.3 billion.Genolair,an omalizumab biosimilar,was launched in Russia whereas ot

119、her biosimilar candidates are in late clinical development.With the entry of these biosimilars in major markets around the world,the drug may experience a significant downtrend in future global revenue.Fig 16:Annual sales(in$USD billions)of Natalizumab(2020-2023)Four years of sales data1.942.060.480

120、.4500.511.522.52020202120222023Yearwise sales data(in$US billions)YearsFig 15:Annual sales(in$USD billions)of Tocilizumab,Ustekinumab,Golimumab,Etanercept,Secukinumab(2020-2023)Four years of sales data0246810122020202120222023Yearwise sales data(in$US billions)YearsTocilizumabUstekinumabGolimumabEta

121、nerceptSecukinumab23Four years of sales dataFig 18:Annual sales(in$USD billions)of Pegfilgrastim(2020-2023)2.291.731.110.600.511.522.52020202120222023Yearwise sales data(in$US billions)Years?ll Sept2023Supportive careSupportive care during serious ailments like cancer is very important for the survi

122、val and recovery of patients.Pegfilgrastim is used to reduce the risk of infection while being treated with cancer medicines and is also used to improve survival in cancer patients who have been exposed to radiation.If we analyze the sales data for the drug,we can clearly see that the drug has exper

123、ienced significantly decreased YoY yield.This is partly due to similar drugs available in the market and stiff competition.However,it is to be noted that data for 2023 is only provided until September i.e.the third quarter as per the final data disclosed by the company.19 biosimilars available world

124、wide indicate that the global pegfilgrastim biosimilars market is growing with increased prevalence of cancer.In comparison to filgrastim,pegfilgrastim provides important medical advantages,such as a 42%relative decrease in the incidence of febrile neutropenia.Pegfilgrastim continues to generate int

125、erest in the biosimilar industry as future pegfilgrastim biosimilars will provide better access to this treatment option.Fig 17:Annual sales(in$USD billions)of Omalizumab(2020-2023)Four years of sales data1.251.41.361.461.11.151.21.251.31.351.41.451.52020202120222023Yearwise sales data(in$US billion

126、s)YearsUnveiling the Potential of Biosimilars:Past Achievements and Future Prospects 4.945.799.61.440246810122020202120222023Yearwise sales data(in$US billions)Y Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsFour years of sales dataFig 19:Annual sales(in$USD billions)o

127、f Aflibercept(2020-2023)Bone healthDenosumab is a fully human monoclonal antibody that targets the receptor activator of NF-B ligand(RANKL),being developed by Amgen.The antibody is available for multiple indications worldwide,which include various bone disorders such as bone metastases,corticosteroi

128、d-induced osteoporosis,giant cell tumour of bone,male osteoporosis,malignant hypercalcaemia,postmenopausal osteoporosis as well as rheumatoid arthritis.As the drug is available in multiple therapeutic areas,this is very well captured in the drugs annual sales data registering$USD 4.5+billion revenue

129、 each year.It is to be noted that the sales data for 2023 is only limited to September 2023(i.e.third quarter)as per company disclosed information.The sale value could very well cross$USD 5 billion in 2023,which accentuates the high demand for the drug in the market.This high demand coupled with lar

130、ge market share induces the biosimilar development companies to take notice and develop biosimilars which can take a slice from this huge market.Denosumab biosimilars are launched in India and China,and recently in Feb 2024,the US FDA approved Wyost and Jubbonti by Sandoz as the first and only FDA-a

131、pproved denosumab biosimilars to treat all indications of the reference products Xgeva and Prolia.OphthalmologyAflibercept is a fully-human recombinant fusion protein that is available in multiple eye disorder therapies,including wet age-related macular degeneration,retinopathy of prematurity,diabet

132、ic retinopathy,retinal oedema,glaucoma,diabetic macular oedema,choroidal neovascularization,retinal vein occlusion as well as colorectal cancer.The availability of the drug in so many indications is also demonstrated in their financial figures with the drug reporting a steep growth in market sales b

133、etween 2020 to 2022.The year 2023 was the weakest for the drug and,with new biosimilars coming up soon,the drug may have trouble returning to its peak figure of 2022.European Commission has approved the first aflibercept biosimilar,Yesafili in March 2024.Biocon Biologics,a subsidiary of Biocon,offic

134、ially announced a settlement with Bayer and Regeneron Pharmaceuticals which allows Biocon Biologics to launch Yesafili in the Canadian market.25OncologyPertuzumab is a recombinant monoclonal antibody,which inhibits HER dimerisation(HDI)for the treatment of HER2(ERBB2)-positive cancers,particularly b

135、reast cancers.The drug has been developed by Roche and the utility of a biologic cancer drug is evident in the sales figure of the drug where it has regularly achieved roughly$USD 4 billion in sales each year.This highlights the prevalence of the disease wherein the availability of biosimilars will

136、help meet the needs of the patients at lower cost.It will be interesting to analyze how the launch of its biosimilar drug affects the sales of the reference drug here.Fig 21:Annual sales(in$USD billions)of Pertuzumab(2020-2023)Four years of sales data3.844.31.0400.511.522.533.544.552020202120222023Y

137、earwise sales data(in$US billions)YearsFour years of sales data4.625.265.644.5201234562020202120222023Yearwise sales data(in$US billions)YearsFig 20:Annual sales(in$USD billions)of Denosumab(2020-2023)Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects 26Table 7A:Pipeline o

138、f reference drugs along with their biosimilars in development Therapeutic focusMetabolic disordersMusculoskeletal disordersAutoimmune disordersImmunological disorderBiologicInsulin aspartTocilizumabUstekinumabGolimumabEtanerceptSecukinumabNatalizumabOmalizumabReference Products(Manufacturer)NovoLog(

139、Novo Nordisk)RoActemra(Chugai Pharmaceutical)STELARA(Centocor)Shinponi(Centocor)Enbrel(Amgen)Cosentyx(Novartis)Tysabri(Elan Corporation)Xolair(Genentech)Pipeline(Manufacturer development stage)Launched PhaseRapilin30(Gan&Lee Pharmaceuticals)Kixelle(Biocon)RinFast(GEROPHARM)TOFIDENCE(Bio-Thera So

140、lutions)Tyenne(Merck KGaA)JamtekiTM(Alvotech)13 biosimilars launchedTyruko(Polpharma Biologics)Genolair(GENERIUM Pharmaceuticals)Registered PhaseBOW-070(EPIRUS Biopharmaceuticals)Etanercept biosimilar(Rus Biopharm),Davictrel(Hanwha Chemical)Preregistered PhaseSAR-Asp(Sanofi)CT-P47(Celltrion)DMB 3115

141、(Dong-A ST),FYB 202(Formycon),SB-17(Samsung Bioepis),Bmab 1200(Biocon)The table below highlights drugs whose biosimilars are planned to be launched very soon along with their other counterparts and their respective development stages as captured from our AdisInsight database.Unveiling the Potential

142、of Biosimilars:Past Achievements and Future Prospects 27Therapeutic focusMetabolic disordersMusculoskeletal disordersAutoimmune disordersImmunological disorderBiologicInsulin aspartTocilizumabUstekinumabGolimumabEtanerceptSecukinumabNatalizumabOmalizumabPipeline(Manufacturer development stage)Phase

143、IIIHS 628(Zhejiang Hisun Pharmaceutical),DRL-TC(Dr Reddys Laboratories),TEMZIVA(AryoGen Pharmed)BAT-2206(Bio-Thera Solutions),CT P43(Celltrion),QX 001S(Qyuns Therapeutics)AVT-05(Alvotech),BAT-2506(Bio-Thera Solutions)SCB 808(Clover Biopharmaceuticals),Enerceptan(Amega Biotech)BAT-2306(Bio-Thera Solu

144、tions)rhuMAb-E25(CuraTeQ Biologics),ADL-018(Adello Biologics),Xolair biosimilar(Celltrion),Aomaishu(Shanghai Zhangjiang Biotechnology),Omalizumab biosimilar(CinnaGen),TEV-45779(Teva Pharmaceutical)Phase II/IIII-004(Amphastar Pharmaceuticals)Phase IIAT-247(Arecor)QX-003S(Qyuns Therapeutics)Phase IBFI

145、-751(BioFactura Australia)RT-111(Rani Therapeutics)SBDM-002(Shilpa Biologicals)BR 201(BioRay Pharmaceutical),CMAB-015(Mabpharm) Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects28Therapeutic focusSupportive careOphthalmologyBone healthOncologyBiologicPegfilgrastimAfliberc

146、eptDenosumabPertuzumabReference Products(Manufacturer)Neulasta(Kirin-Amgen)EYLEA(Regeneron Pharmaceuticals)Xgeva(Amgen)Perjeta (Genentech)Pipeline (Manufacturer development stage)Launched Phase19 biosimilars launchedMAILISHU (Jiangsu T-mab BioPharma),Boluojia (Luye Pharma),DenosuRel (Reliance Life S

147、ciences)Registered PhasePegfilgrastim biosimilar(Rus Biopharm),FILPEGLA(Cipla),Pegfilgrastim biosimilar(Hospira)Yesafili(Momenta Pharmaceuticals)Denosumab biosimilar(Intas Pharmaceuticals)Preregistered PhaseFYB-203(Formycon)GP-2411(Hexal)Phase IIISB-15(Samsung Bioepis),BA-9101(Shandong Boan Biotechn

148、ology)SOK583A1(HEXAL),AVT-06(Alvotech),CT-P42(Celltrion),ABP 938(Amgen),ALT L9(Alteogen),SBDM-004(Shilpa Biologicals),Aflibercept biosimilar(CinnaGen),SCD-411(Sam Chun Dang Pharm),QL1207(Qilu Pharmaceutical),9MW-0813(Mabwell(Shanghai)Bioscience)HLX 14(Shanghai Henlius Biotech),SB 16(Samsung Bioepis)

149、,RGB 14-P(Gedeon Richter),FKS-518(Fresenius Kabi),CT-P41(Celltrion),CMAB-807(Shanghai Biomabs Pharmaceuticals),QL-1206(Qilu Pharmaceutical),ENZ-215(Alkem Laboratories)QL-1209(Qilu pharmaceutical),Pertuzumab biosimilar(CinnaGen),BCD-178(Biocad),SYSA-1901(CSPC ZhongQi Pharmaceutical Technology),TQB-24

150、40(Chia Tai Tianqing Pharmaceutical Group),HLX 11(Shanghai Henlius Biotech)Table 7B:Pipeline of reference drugs along with their biosimilars in Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects29Therapeutic focusSupportive careOphthalmologyBone healthOncologyBiologicPegfi

151、lgrastimAfliberceptDenosumabPertuzumabPipeline (Manufacturer development stage)Phase IIXZP-KM118(Xuanzhu Biopharmaceutical)Phase IDYRUPEG(CuraTeQ Biologics),TX-04(Tanvex Biopharma)EG-1206A(Genentech),Pertuzumab biosimilar(Mabscale)Unveiling the Potential of Biosimilars:Past Achievements and Future P

152、rospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsGlobal distribution of upcoming biosimilarsDetailed analysis of all upcoming biosimilars revealed that China is emerging as a key player in the global biosimilar market with 22 biosimilars in the pipeline,followed

153、by the USA having 19 biosimilars in the pipeline.Fig.22:Distribution by country of upcoming biosimilarsGeographical distribution of upcoming biosimilarsNumber of upcoming biosimilars 31Snapshot of biosimilars 2023 and beyondFig.23:A roadmap of upcoming biosimilars2 0 2 92 0 2 52 0 2 42 0 2 32029Etan

154、ercept (Enbrel)2024/2025Pertuzumab (Perjeta)2024/2025Golimumab (Simponi)2024Aflibercept (Eylea)2023Pegfilgrastim (Neulasta Onpro)2023Insulin aspart (NovoLog)2029Secukinumab (Cosentyx)2025Omalizumab (Xolair)2025Denosumab (Prolia/Xgeva)2023/2024Natalizumab (Tysabri)2023/2024Ustekinumab (Stelara)2023To

155、cilizumab (Actemra)Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future ProspectsKey players in the upcoming marketWith the expiration of patents on several blockbuster biologics,pharmaceutical companies are

156、 actively investing in the development of biosimilar products.These companies are actively engaged in clinical-stage development,focusing on various therapeutic areas.Cellitron,Sandoz,Teva Pharmaceuticals and Ligand Pharmaceuticals are some of the key players making significant contributions to the

157、biosimilars market.Their dedication to innovation and commitment to improving patient access to affordable biologic therapies position them as frontrunners in this high-potential market.The following are the top three players with their respective biosimilars in development:Fig 24:Top 15 companies i

158、nvolved in upcoming biosimilarsUpcoming key players in clinical developmentTop three companies Fig 25:Top three companies for upcoming biosimilars 012345678Number of biosimilarsCompaniesTrastuRelTrastuzumabbiosimilar-EirGenixSandozCelltrionTevaTyrukoTVB-009NypoziUpcomingCT-P47RT-111CT-P53CT P43CT-P

159、39CT-P41CT-P42GP-2411SB-17SOK583A1AVT 04Tuznue AVT-05AVT-06TEV-45779RegisteredPreregisteredClinicalConclusionIn this report,we have analyzed the impact of biosimilar launches on the sales of the original biologic,the landscape of anticipated biosimilar launches,and the key market players.This conclu

160、sion synthesizes data-driven insights to offer a forward-looking perspective on the biosimilar industrys trajectory.Our analysis reveals a notable trend of decreasing sales for original biologics following the introduction of biosimilars,with an average sales decline of 20-30%.This effect underscore

161、s the competitive pricing strategies employed by biosimilar manufacturers,which,in turn,have fostered a more cost-conscious healthcare environment.The data suggests that the presence of biosimilars not only catalyzes price reductions but also expands patient access to essential therapies.Looking ahe

162、ad,the pipeline of upcoming biosimilars is robust,targeting treatments for a range of conditions from autoimmune diseases to cancers.This surge emphasizes a growing industry focus on biosimilar development,propelled by the impending expiry of patents for several high-profile biologics.The biosimilar

163、 market landscape is characterized by a mix of established pharmaceutical giants and emerging biotech firms.Companies such as Reliance,Pfizer,and Sandoz are noted for their extensive portfolios and aggressive expansion strategies into new therapeutic areas.Meanwhile,emerging players such as Teva,Cel

164、ltrion and Samsung Bioepis are carving out niches through innovative manufacturing techniques and strategic partnerships.The interplay among these entities fosters a vibrant competitive environment,driving innovation,and ensuring a continuous supply of biosimilars to meet growing demand.In essence,t

165、he biosimilar market is at a critical juncture,with significant opportunities and challenges ahead.The data-driven analysis of sales impact,upcoming launches,and key market players provides a nuanced understanding of the current state and prospects of biosimilars.Stakeholders across the healthcare e

166、cosystem must navigate regulatory complexities,market acceptance,and the intricacies of biologic drug development to fully capitalize on the potential of biosimilars.As we move forward,the strategic actions of these stakeholders will determine the pace at which biosimilars can contribute to sustaina

167、ble healthcare systems and improved patient outcomes Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects33About AdisInsightYou need data insights to deliver your organizations objectives and overcome your biggest challenges.That data needs to be trustworthy,up to date,and a

168、ccurate.How to access and use that data should be up to you:thats why we give you flexibility and control.You can opt to get our rich,validated data plugged straight into your internal analytics platforms and systems,so you have the freedom to explore and interrogate the data to meet your specific n

169、eeds.Our organizations objectives and overcome your biggest challenges.That data needs to be trustworthy,up to date,and accurate.How to access and use.In drug development where every day matters,our platform and solutions empower you to quickly understand whats happening and why,so you can reduce ri

170、sk,make smarter strategic decisions and act with complete confidence.To find out more visit AdisInsight on Contact 34030VJ-4th|Image:Tatiana Shepeleva/ Unveiling the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future Pr

171、ospectsReferences:1.Home-AdisInsight()2.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars3.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs/what-are- Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases.() the Potential of Biosimilars:Past Achievements and Future Prospects Unveiling the Potential of Biosimilars:Past Achievements and Future P