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.pdf

UnveilingthePotentialofBiosimilars:PastAchievementsandFutureProspectsadisinsight.springer.com2ContentsIntroduction3Biosimilarsversusgenerics3Advantagesofbiosimilars3Globaldistributionofbiosimilarsapprovals(5years)4Thefirstbiosimilar9Changeinregulatoryguidelinesfortheapprovalprocess10Interchangeablebiosimilars10Salesanalysisofreferencebiologicpostbiosimilarlaunch(2019-2023)11ComparativeaccountofYear-Over-Yearsalesofreferenceproducts16Globaldistributionoflaunchedbiosimilars18Keyplayersinthemarketforlaunchedbiosimilars19Thenextwaveofbiosimilars20Globaldistributionofupcomingbiosimilars27Keyplayersintheupcomingmarket29Conclusion30References32UnveilingthePotentialofBiosimilars:PastAchievementsandFutureProspectsadisinsight.springer.comIntroductionBiosimilarsaresafeandeffectivetreatmentoptionsformanyillnesses,suchaschronicskinandboweldiseases(likepsoriasis,irritablebowelsyndrome,Crohn’sdisease,andcolitis),arthritis,kidneyconditions,andcancer.Thesemedicinesareverycloseinstructureandfunctiontobiologicmedicinesandincreaseaccesstolifesavingmedicationsatpotentiallylowercosts.Theyarehighlysimilartoabiologicmedicationalreadyapprovedbyaregulatorybody–theoriginalbiologic(alsocalledthereferenceproduct).Bothabiosimilaranditsoriginalbiologic:•Aremadefromthesametypesofsources(e.g.livingsources)•Providethesamebenefitswhentreatingdiseasesormedicalconditions•Areprovidedatthesamestrengthanddosage•ArenotexpectedtocauseneworworseningsideeffectsBiosimilarsversusgenericsBiosimilarsandGenericsarealternateversionsofmedicationsthatarealreadyapprovedbyaregulatorybody,butthesetwotypesofmedicinesshowsomesignificantdifferences:Advantagesofbiosimilars•Biosimilarsprovidealower-costoptiontoreplaceoriginal-brandproducts•Improveaccesstopatientswhencomparedtothereferencebiologics•Providemoretreatmentoptionsforpatientswithseriousandlife-threateningdiseases•Similarlyeffectiveasthereferencebiologicalmedicines3BiosimilarsGenericsGenerallymadefromlivingorganismsVERSUSGenerallymadefromchemicalsRequireaspecializedprocessHaveasimplerprocesstocopyVerysimilarbutnotidenticaltooriginalbiologicCopyofbrand-namedrugsFasterdevelopmentprocessusingpublicinformationfromoriginalbiologicapprovalFasterdevelopmentprocessusingpublicinformationfrombrand-namedrugapprovalUsuallylessexpensivethanoriginalbiologicUsuallylessexpensivethanbrand-namedrugsadisinsight.springer.comUnveilingthePotentialofBiosimilars:PastAchievementsandFutureProspectsGlobaldistributionofbiosimilarsapprovals(5years)Inrecentyears,biosimilarshavegainedsignificantattentionandimportanceinhealthcare,particularlyintheUnitedStatesandEurope.Thesebiologicalproducts,whicharehighlysimilartoreferencebiologicmedicines,offerincreasedaccesstocost-effectivetreatmentsandcanpotentiallylowerhealthcareexpenditures.In2019,theUnitedStateswitnessedaremarkablenumberofbiosimilarsbeingapproved,whichresultedintheFoodandDrugAdministration(FDA)grantingmarketingauthorizationtoarecord-breakingnumberoftheseproducts(10).TheseFDAapprovalscoveredvarioustherapeuticareas,inclu