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

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