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2024探索生物类似药的潜力历史成就与未来前景研究报告-英文版

医药生物2024-06-05-AdisInsight邓***

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Unveiling the Potential of Biosimilars: Past Achievements and Future Prospects

Biosimilars, serving as safe and effective alternatives for treating various chronic illnesses, are gaining prominence in healthcare due to their ability to provide affordable treatment options. These medicines, closely resembling biologic medicines, increase accessibility to life-saving medications while potentially reducing healthcare costs.

Advantages of Biosimilars:

Cost-effectiveness: Biosimilars offer a lower-cost alternative to original biologic products.
Increased Access: They improve patient access to medications when compared to the reference biologics.
Treatment Diversity: They provide additional options for patients suffering from severe or life-threatening diseases.
Similar Effectiveness: They are as effective as the original biologic medicines.

Comparison between Biosimilars and Generics:

Origin of Medicine: Biosimilars are derived from living sources, whereas generics are typically chemical-based.
Manufacturing Process: Biosimilars require a complex, specialized process, while generics undergo a simpler process to replicate.
Similarity vs. Difference: Biosimilars are highly similar but not identical to the original biologic medicine, while generics aim to be chemically equivalent.

Global Distribution of Biosimilars Approvals: In the past five years, both the FDA and EMA have approved a significant number of biosimilars:

United States (USA): 28 biosimilars were approved from 2019 to 2023.
Europe (EU): 30 biosimilars were approved within the same period. These approvals primarily catered to oncology, immunology, and endocrinology, reflecting the growing demand for affordable biologic treatments.

Sales Analysis of Reference Biologics Post-Biosimilar Launch: From 2019 to 2023, sales of reference biologic products experienced notable changes following the introduction of biosimilars, indicating potential shifts in market dynamics and patient access.

Key Players in the Market:

USA: Companies like Amgen, Pfizer, Samsung Bioepis, and Celltrion led the biosimilar market.
Europe: Pfizer, Samsung Bioepis, and Celltrion were among the key players.

Upcoming Wave of Biosimilars: The global landscape anticipates a surge in biosimilars, with a focus on expanding market reach and improving patient access to innovative treatments.

Conclusion: Biosimilars represent a promising avenue in healthcare, offering a balance between efficacy and affordability. With increasing approvals and market presence, they are poised to significantly impact the landscape of biologic treatments, enhancing patient access and potentially reducing healthcare costs globally.

adisinsight.springer.com UnveilingthePotentialofBiosimilars: PastAchievementsand FutureProspects ContentsIntroduction 3 Biosimilarsversusgenerics 3 Advantagesofbiosimilars 3 Globaldistributionofbiosimilarsapprovals(5years) 4 Thefirstbiosimilar 9 Changeinregulatoryguidelinesfortheapprovalprocess 10 Interchangeablebiosimilars 10 Salesanalysisofreferencebiologicpostbiosimilarlaunch(2019-2023) 11 ComparativeaccountofYear-Over-Yearsalesofreferenceproducts 16 Globaldistributionoflaunchedbiosimilars 18 Keyplayersinthemarketforlaunchedbiosimilars 19 Thenextwaveofbiosimilars 20 Globaldistributionofupcomingbiosimilars 27 Keyplayersintheupcomingmarket 29 Conclusion 30 References 32 Introduction Biosimilarsaresafeandeffectivetreatmentoptionsformanyillnesses,suchaschronicskinandboweldiseases(likepsoriasis,irritablebowelsyndrome,Crohn’sdisease,andcolitis),arthritis,kidneyconditions,andcancer.Thesemedicinesareverycloseinstructureandfunctiontobiologicmedicinesandincreaseaccesstolifesavingmedicationsatpotentiallylowercosts.Theyarehighlysimilartoabiologicmedicationalreadyapprovedbyaregulatorybody–theoriginalbiologic(alsocalledthereferenceproduct). Bothabiosimilaranditsoriginalbiologic: •Aremadefromthesametypesofsources(e.g.livingsources) •Providethesamebenefitswhentreatingdiseasesormedicalconditions •Areprovidedatthesamestrengthanddosage •Arenotexpectedtocauseneworworseningsideeffects Biosimilarsversusgenerics BiosimilarsandGenericsarealternateversionsofmedicationsthatarealreadyapprovedbyaregulatorybody,butthesetwotypesofmedicinesshowsomesignificantdifferences: Biosimilars VERSUS Generics Generallymadefromlivingorganisms Generallymadefromchemicals Requireaspecializedprocess Haveasimplerprocesstocopy Verysimilarbutnotidenticaltooriginalbiologic Copyofbrand-namedrugs Fasterdevelopmentprocessusingpublicinformationfromoriginalbiologicapproval Fasterdevelopmentprocessusingpublicinformationfrombrand-namedrugapproval Usuallylessexpensivethanoriginalbiologic Usuallylessexpensivethanbrand-namedrugs Advantagesofbiosimilars •Biosimilarsprovidealower-costoptiontoreplaceoriginal-brandproducts •Improveaccesstopatientswhencomparedtothereferencebiologics •Providemoretreatmentoptionsforpatientswithseriousandlife-threateningdiseases •Similarlyeffectiveasthereferencebiologicalmedicines Globaldistributionofbiosimilarsapprovals(5years) Inrecentyears,biosimilarshavegainedsignificantattentionandimportanceinhealthcare,particularlyintheUnitedStatesandEurope.Thesebiologicalproducts,whicharehighlysimilartoreferencebiologicmedicines,offerincreasedaccesstocost-effectivetreatmentsandcanpotentiallylowerhealthcareexpenditures. In2019,theUnitedStateswitnessedaremarkablenumberofbiosimilarsbeingapproved,whichresultedintheFoodandDrugAdministration(FDA)grantingmarketingauthorizationtoarecord-breakingnumberoftheseproducts(10).TheseFDAapprovalscoveredvarioustherapeuticareas,includingoncology,immunology,andendocrinology.ThegreateravailabilityofbiosimilarsintheUnitedStatesisexpectedtoenhancecompetition,potentiallyleadingtoreducedhealthcarecostsandincreasedpatientaccesstocriticalbiologicaltreatments. TheEuropeanMedicinesAgency(EMA)hasbeeninvolvedintheapprovalofbiosimilarsinEuropesince2006.Europehasbeenattheforefrontofbiosimilaradoption,withthehighestnumberofbiosimilarapprovalsobservedinpreviousyears.Asof2021,theEuropeanUnionhascontinuedtoseeasignificantnumberofbiosimilarapprovals(9),withnumerousproductsgainingauthorizationforuse. Biosimilarsapprovedin5years 12 Numberofdrugsaaproved 10 8 6 4 2 0 20192020202120222023 USAEurope Year Fig.1:Yearlytrendofbiosimilarsapprovedfrom2019-2023inUSandEU InthelastfiveyearstheUSFDAandEMAhaveapproved28and30biosimilarsrespectively(Table1andTable2).Thehighestnumberofbiosimilarshavebeenapprovedforcancer(19),followedbyimmunologicaldisorders(17). Table1:ApprovedbiosimilarsinUSA(5Years) Name CompanyName FDAApprovaldate Actemra(tocilizumab)biosimilars Tofidence(tocilizumab-bavi) BiogenInc. 29-Sep-23 Avastin(bevacizumab)biosimilars Avzivi(bevacizumab-tnjn) Bio-TheraSolutions,Ltd. 6-Dec-23 Vegzelma(bevacizumab-adcd) Celltrion,Inc. 27-Sep-22 Name CompanyName FDAApprovaldate Alymsys(bevacizumab-maly) AmnealPharmaceuticals,Inc. 13-Apr-22 Zirabev(bevacizumab-bvzr) PfizerInc. 27-Jun-19 Enbrel(etanercept)biosimilars Eticovo(etanercept-ykro) SamsungBioepisCo.,Ltd. 25-Apr-19 Herceptin(trastuzumab)biosimilars Kanjinti(trastuzumab-anns) AmgenInc. 13-Jun-19 Trazimera(trastuzumab-qyyp) PfizerInc. 11-Mar-19 Ontruzant(trastuzumab-dttb) SamsungBioepisCo.,Ltd. 18-Jan-19 Humira(adalimumab)biosimilars Yuflyma(adalimumab-aaty) Celltrion,Inc. 23-May-23 Idacio(adalimumab-aacf) FreseniusKabi 13-Dec-22 Yusimry(adalimumab-aqvh) CoherusBioSciences,Inc. 17-Dec-21 Hulio(adalimumab-fkjp) MylanPharmaceuticalsInc. 6-Jul-20 Abrilada(adalimumab-afzb) PfizerInc. 15-Nov-19 Hadlima(adalimumab-bwwd) SamsungBioepisCo.,Ltd. 23-Jul-19 Lantus(insulinglargine)biosimilars Rezvoglar(insulinglargine-aglr) EliLillyandCompany 17-Dec-21 Lucentis(ranibizumab)biosimilars

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