艾昆纬-美国生物仿制药2023-2027 Biosimilars in the United States 2023–2027

BiosimilarsintheUnitedStates2023–2027COMPETITION,SAVINGS,ANDSUSTAINABILITYJANUARY2023IntroductionentdingidereheUSVIAeegratefullyacknowledged.FindOutMoreMURRAYAITKENExecutiveDirectorIQVIAInstituteforHumanDataSciencectionrightsquotationsbroadcastingpublicationsreservedNopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeanselectronicormechanicalincludingphotocopyrecordingoranyinformationstorageandretrievalsystemwithoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute.Overview2Marketdynamicsandbiosimilardevelopment4Factorsinfluencingbiosimilaruptake13Biosimilarimpactsonmoleculevolumeandprice20Futureimpactsofbiosimilars26Notesonsources33Definitionsandmethodology34References35Abouttheauthors36AbouttheInstitute38|3BIOSIMILARIMPACTSONMOLECULEVOLUMEANDPRICEtreatmentssweremorecostlyincludingreducingotherhealthcaresystemparticipants.Pricereductionsanddiscountsandrebates.FUTUREIMPACTSOFBIOSIMILARSmngthemesSavingsasaresultofbiosimilarsareprojectedtoexceed$180Bnoverthenextfiveyears.wthteUSMarketMarketdynamicsandbiosimilardevelopmentlbutedntadvantageavelaunchesThebiologicsmarketcontinuestogrow,with14%ofthemarketfacingbiosimilarcompetition,anumberlikelytogrowby15%in2023asbiosimilarsareexpectedtolaunchformoleculeswithhigh|5%5.6% MARKETDYNAMICSANDBIOSIMILAR%5.6% TheU.S.biologicsmarketcontinuestogrowfasterthannon-biologicsonaninvoice-basis,andnowcomprises46%ofspendingExhibit1:TotalU.S.invoicespendinggrowthbytypeandleadingtherapyareasby2021spending,US$Bns Immunologys Immunology90 Antidiabetics84 Oncology78 e ntithrombotics ntithromboticsspendingBnhealth Pain1246%%14%12%10%8%6%4%2%0%2021mallmoleculeTotalUSmedicinesInstituteNovsthmatreatmentsentsncludestherapeuticagentsaswellassupportivecareInvoicepricesinthisreportareexmanufacturerlevelreflectingthepricesbetweenanufacturersandtheircustomerswholesalersordirectpurchasersnotincludingoffinvoicediscountsandrebatesMoleculeswithbiosimilarsindevelopment$96Bn53%Biologicsmarket$260Bn47%Moleculeswithbiosimilarsindevelopment$96Bn53%Biologicsmarket$260Bn47%Moleculeswithoutbiosimilarsindevelopment$86BnMoleculeswithbiosimilarstotal$38Bnofinvoicespending,whilebiosimilardevelopmentistargetingafurther$96BnExhibit2:2021biologicsmarketsegmentedbystatusofbiosimilarcompetitionandbiosimilardevelopmentMoleculesMoleculesfacingbiosimilarcompetition$38BnMoleculesMoleculeswithpotentialfuturebiosimilars$181BnNonNon-recombinant/vaccines$41BnSourceIQVIAMIDASDecIQVIAPipelineIntelligenceIQVIAInstituteNov022.ngorsiesetogicsincludeglatirameracetateenoxaparinsodiumandarangeofvaccinesandbloodplasmaproductsNumbers|7Originatorprotected$89Bn93%Moleculeswithbiosimilarsindevelopment$96BOriginatorunprotected$7BnOriginatorprotectedOriginatorprotected$89Bn93%Moleculeswithbiosimilarsindevelopment$96BOriginatorunprotected$7BnOriginatorprotected$77Bn90%Moleculeswithoutbiosimilarsindevelopment$86BOriginatorunprotected$9BnMostofthemoleculeswithbiosimilarsindevelopmentcontinuetobeprotected,withonly7%unprotectedExhibit3:2021biologicsmarketsegmentedbystatusofbiosimilardevelopmentandmarketexclusivity21moleculesAvgsales=$4.2Bn6moleculesAvgsales=$1.2Bn145moleculesAvgsales=$532Mn33moleculesAvgsales=$260MnSourceIQVIAMIDASDecIQVIAPipelineIntelligenceIQVIAInstituteNov022.dturerewhileunprotectedisdefinedashavinganexpirydateinthepastNumbersmaynotsumduetorounding.eeBiosimilarslaunchedtodateaccountfor24%ofcompetitivemoleculevolumeExhibit4:Percentageofbiologicssalesaccessibletoapprovedandlaunchedbiosimilarsandbiosimilarefficiency,Q12015–Q3202240%5%0%5%0%5%0%chedUSVIAMIDASSepIQVIAInstituteDecalationandothersuesedeilarshareofmarketvolumewherebiosimilarsareapprovedandlaunchedandforthisexhibitiscalculatedbased|91234132312156123413142234511231212781-MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT1234132312156123413142234511231212781-Since2007,30biosimilarshavelaunchedintheU.S.with10moreapprovedandsettolaunchbytheendof2023Exhibit5:BiosimilarsapprovedandlaunchedintheU.S. 1144QVIAInstituteDectedthwaysrandsimilarsapprovedbutnotyetlaunchedareplacedbasedonexpectedlaunchannouncedbycompanyApprovedetanerceptEnbrelbiosimilarsnotTherearebiosimilarsapprovedorinclinicaldevelopmentintheU.S.for20additionalmoleculesExhibit6:Cumulativemoleculespendingandapproved,launchedandpipelinebiosimilarproductsforthemolecule0255075100165-5051015MoleculesMoleculeswithlaunchedbiosimilarsMoleculeswithnolaunchedbiosimilarsDiscontinuedLaunchedApprovedbutnotlaunchedPhaseItopre-regPreclinicaltodiscoveryourceIQVIAMIDASDecIQVIAPipelineIntelligenceIQVIAInstituteDecrettedfewerpropertyissues.|11MARKETDYNAMICSANDFormoleculesfacingbiosimilars,competitivenessishighlyvariedbutlargeshareforlatercompetitorsisrareExhibit7:MarketconcentrationHerfindahl-HirschmanIndexandsharesbycompetitorQ320220.0ilarVIAMIDASSepIQVIAInstituteDectolemarkettakeineisnormalizedtoastandardizeddoseperdaytoadjustforformulationdifferencesbetweenoriginatorsandbiosimilarsericsarethosemedicinesmarketedorauthorizedbytheoriginatorusingnonproprietarynamingbutarethesameastheoriginatorproductandincludedintheoriginatorshareSomatropinhassixoriginatorproducts.MARKETDYNAMICSANDBIOSIMILARDEVELOPMENTDevelopmentofbiosimilarsisbeingdrivenbysmallercompanies,whilemarketingisdonemostlybylargecompaniesExhibit8:BiosimilarsindevelopmentandmarketedintheU.S.bycompanytypeandsize90%80%70%60%50%40%30%20%10%0%LargepharmaurceIQVIAGlobalBiosimilarsDatabaseSepIQVIAInstituteNovheonleretoicherreferstoallothercompanieswithabiosimilarindevelopmentregardless|13FactorsFactorsinfluencingbiosimilaruptakeeementdynamicsefaricsnMoleculeswithbiosimilarsfirstlaunchedin2019haveseensignificantbiosimilaruptakeinthelastthreeyears,thoughvariabilitystillexistsacrosscaresettingsintheuseofbiosimilars.FACTORSINFLUENCINGBIOSIMILARRecentbiosimilarshaveachievedhighvolumeshares,reachingmorethan60%withinthefirstthreeyears,varyingbychannelExhibit9:Biosimilarshareofvolumesincebiosimilarlaunch%80%70%60%50%40%30%20%10%0%90%80%70%60%0%024681012141618202224262830323436Monthssincebiosimilarintroductionbevacizumab7/2019filgrastim11/2013alfaMIDASIQVIADDDOctIQVIAInstituteDecMonthssincebiosimilarintroduction340BAllothers340BAllothersOverallserproductseunitshareswithoutdaysoftherapynormalizationresultingindifferencesinoverallsharecomparedtodinE|15FACTORSINFLUENCINGBIOSIMILARUPTAKEMostprovidersareusingabiosimilarofbevacizumabmorethantheoriginator,withfewfavoringtheoriginatorExhibit10:UseofbiosimilarsandoriginatorbevacizumabwithinoutletsOriginatorandbiosimilarsshareofbevacizumabvolumedistributedtooutlets2020vs.202260%50%40%30%20%10%0%BiosimilarshareOriginator2022Originator2020Biosimilars2022Biosimilars202090%80%70%60%50%40%30%20%10%0%viderpreferences.easelstialTopcombinesmaynotrepresentthesameoutlets.%80%%80%70%60%50%40%30%20%0%024681012141618202224Biosimilarshavehadstrongeruptakeinbuy-and-bill,wherephysicianshaveincentivetoselectoneproductoveranotherExhibit11:Averagebiosimilarnewpatientmarketshareovertimebybillingtype%80%70%60%50%40%30%20%10%0%024681012141618202224MonthssincelaunchBymoleculerketAccessStrategyConsultingDecents|1790%80%70%60%50%40%30%20%90%80%70%60%50%40%30%20%0%BiosimilarproductsweremorereadilyadoptedamongprofessionalproviderscomparedtoinstitutionalExhibit12:Averagebiosimilarnewpatientmarketshareovertimebyprovidertype90%80%70%60%50%40%30%20%10%0%44% 48%024681012141618202224024681012141618202224rketAccessStrategyConsultingDecorsntractingandreimbursementstoaftertwoyears.udebevacizumabepoetinalfatrastuzumabpegfilgrastiminfliximabandrituximab90%80%70%90%80%70%60%50%40%30%20%0%024681012141618202224ProvidersparticipatingintheOncologyCareModeladoptedbiosimilarsathigherlevelscomparedtonon-participantsExhibit13:AverageoncologybiosimilarnewpatientmarketshareovertimebyproviderOCMstatus90%80%70%60%50%40%30%20%10%0%024681012141618202224MonthssincelaunchrketAccessStrategyConsultingDecFFSess•ThedifferencesinuptakewerelikelydrivenbytheincentivesforOCMparticipantstoreducecosts,andOCMpracticesnotedthatutilizinglower-costbiosimilarswasarelativelyeasymethodforreducingcostspertreatment.5NotesEvaluatedbiosimilarsincludeoncologyandsupportivecarerelatedmoleculesbevacizumabepoetinalfatrastuzumabpegfilgrastim,and|19BasaglarSemgleecgBasaglarSemgleecg cInterchangeabilityhasincreasedbiosimilarusewherebiosimilaruptakehasremainedlowduetooriginatordefensestrategiesExhibit14:Insulinmonthlyshareofdefineddailydoses(DDDs)byproduct,Jan2016–Nov202290%80%90%80%70%60%50%40%30%20%0%r8%8%0%0%0%%40%0%0%0%IAMIDASNovIQVIAInstituteJanontarerotingtedicinesmarketedorauthorizedbytheoriginatorusingnonproprietarynamingbutarethesameastheoriginatorsabiosimilarapprovedthroughthebpathwaySemgleeisabiosimilarsioninLyumjevisanoriginatorlaunchedproductofinsulinogAdmelogisabiosimilarapprovedthroughthekpathwayBiosimilarBiosimilarimpactsonmoleculevolumeandpricevealternativetreatmentscanleadtovolumegenerationproducts.ingtiverIntroductionofbiosimilarsfrequentlyleadstoincreasedaccessofabiologicmedicinetopatientsdrivenbylowercostsofbiosimilarsandpricereductionsof|21aBIOSIMILARIMPACTSONMOLECULEVOLUMEANDPRICEaExhibit15:Incrementalvolumeafterbiosimilarentrycomparedtopriortrend 8642086420inestim000teriparatide8642086420 04320 1VIAMIDASSepIQVIAInstituteDecation0Percentageation001234ntexinginnovativediabetestreatments.basnangeinvolumeiscalculatedcomparingthemoleculetotalvolumetothetedvolumefromthepreexpirytrendBIOSIMILARIMPACTSONMOLECULEVOLUMEExhibit16:Quarterlyshareofdefineddailydoses(DDDs)byoriginators,secondgenerationoriginators,andbiosimilarsintheU.S.0%Neulasta*Neulasta*Neupogen*0%%40%0%0%0%90%80%70%60%50%40%30%20%10%0%PPerjetaPhesgoEnhertuHerceptin*VIAMIDASSepIQVIAInstituteDecsroductsashetathewingtandNotes:*Originatorproductwherebiosimilarsareavailableforthesamemolecule:filgrastim(Neupogen),pegfilgrastim(Neulasta),trastuzumab(Herceptin).Trastuzumabemtasine(Kadcyla)andtrastuzumabderuxtecan(Enhertu)areantibody-drugconjugates.Pertuzumab(Perjeta)isanewergenerationbreastitionPertuzumabtrastuzumabhyaluronidasePhesgoisafixeddosecombinationofPerjetaandHerceptininaectionHerceptinincludesHerceptinH|23ChangeincostperextendedunitrelativeChangeincostperextendedunitrelativetoonemonthpriortobiosimilarlaunchIntroductionofabiosimilarhasdrivendowntotalmoleculecosts18–50%withrateofdeclinedrivenbybiosimilaruptakeExhibit17:Changeincostperextendedunitfollowingbiosimilarlaunchrelativetopre-expirycost0%0%-50%04812162024283236404448525660646872768084bevacizumabepoetinalfafilgrastiminfliximabpegfilgrastimrituximabtrastuzumabSourceIQVIANationalSalesPerspectiveUSMarketAccessStrategyConsultingDec022.ngthelargest.mfiveyears.rebatesExtendedunitsrepresentnumberextendedunitswerenormalizedtotheamountofactiveingredientperextendedunit.hBIOSIMILARIMPACTSONMOLECULEVOLUMEANDPRICEhereExhibit18:OriginatorandmeanbiosimilarAverageSalesPrice(ASP)inUS$,Oct2022 Absoluteandpercentagepricedifferencebetweenoriginatorpre-expiryandbiosimilaraveragesalespricectIQVIAInstituteDecbfeofsndingpharmacymarkupsfedDecInsulinsabasofOctASPpricesnormalizedtoardbodysurfaceareameters|25hBIOSIMILARIMPACTSONMOLECULEVOLUMEhExhibit19:ChangeinoriginatorAverageSalesPrice(ASP)inUS$andvolume3%3% trastuzumab -80%-60%-40%-20%0%20%osimilarOriginatorvolumechangepre-biosimilarvs.Q32022-100%-80%-60%-40%-20%0%tIQVIAMIDASSepIQVIAInstituteDecingheaveirlyndtheseoriginators.gandardbodysurfaceareameterssquaredFutureFutureimpactsofbiosimilarsmicseSavingsfrombiosimilarsareexpectedtoexceed$180Bnoverthenextfiveyears—amorethanfour-foldincreasefromthelastfiveyears—drivenbysignificantbiosimilarlaunchesinimmunology,includingforH|27FUTUREIMPACTSOFBIOSIMILARSVolumeuptakescenariosincludehigh,mediumandlow,tiedtobothoriginatorcompetitionandpricereductionsrangingfrom15–45%Exhibit20:Modelingofscenariosbasedonaverage(basecase),highandlowexamplestodate70%24%40%0%0%0%4MIDASJunIQVIAInstituteNovareprovidersdllayersearuptakeintermsofvolumeandpricediscountsrelativetooriginatorsarebasedonIQVIAInstituteanalysisofhistoricanalogues.FUTUREIMPACTSOFBIOSIMILARSExpectedlaunchesanduptakearelikelytoincreaseoverallspendingonbiosimilarssignificantlyto$20–49Bnin2027Exhibit21:Biosimilarhistoricalsales2013–2022andoutlookscenarios2023–2027,US$Bn04MIDASJunIQVIAInstituteNovuntshnealesvaluesshownintheoutlookscenariosreflectassumptionsforhighlowandaveragebasecasevetooriginatorsTimingofexpectedbiosimilarentrybasedonpatentinformationandlitigation|29Savingsoverthenextfiveyearsasaresultofbiosimilarsareprojectedtoexceed$180Bn,thoughuncertaintiesremainExhibit22:Biologicestimatedsavingsfrombiosimilarsatinvoiceprices042.941.02.93.03.0MIDASJunIQVIAInstituteNovrstesaringactualmoleculespendingtoprojectedspendingiftotalmoleculevolumehadbeenatoriginatorpresbasedonestimatedcontinuingimpactofbiosimilareventsinprogressaswellasfutureexpectedexpiriesTherangeforhighlowandaveragebasecasebiosimilarvolumeuptakeandpriceimilarentrybasedonpatentinformationandlitigationsettlementsasofOct1%9%1%9%1%9%7%5%3%1%8%6%5%5%8%8%9%9%54%29%17%Entryofnewimmunologybiosimilarsin2023willincreasecompetitioninarapidlygrowingmarketExhibit23:Historicandfutureimmunologyvolumeindefineddailydoses(DDDs)bybiosimilarcompetition,SmallmoleculeBiologicswithbiosimilarsJunIQVIAInstituteDecetrow•Thesebiosimilarlauncheswillincreasetheshareoftotalimmunologyvolumeaccessibletobiosimilars,from25%in2022to55%in2023,andtwo-thirdsofbiologicvolumeintheimmunologymarketwillfacebiosimilarcompetition.eedhofmebasedoncurrentgrowthtrendsandtedbiosimilarentrybasedonpatentinformationandlitigationsettlementsasofO|31FUTUREIMPACTSOFBIOSIMILARSProductcharacteristicsandreimbursementdecisionsarelikelytoimpactadalimumabbiosimilaruptakebeginningin2023Exhibit24:TimelineofadalimumabbiosimilarentryandlessonsfromEuropeWaveofbiosimilarlaunches•6lowconc.:5arecitrate-free;1(possibly2)interchangeableatlaunch•2additionalhighconc.submittedtoFDA,onewithinterchangeabilityJanuarySeptemberJanuaryJulyFirstbiosimilarlaunchfree•Highconc.,interchangeabilitytrialcompletedinDec2022Laterbiosimilarsandinterchangeability•1additionallowconc.launch•PreviouslaunchedbiosimilarscouldachieveinterchangeabilityVIAMIDASSepIQVIAInstituteDecShareofadalimumabvolumeinEU4+UKbyproduct100%90%80%70%100%90%80%70%60%50%40%30%20%10%0%ehaveedroppedto30%.similarlaunchtimelinesandproductcharacteristicsbasedonpubliclyreportedcompanystatementsFDAlabelsandEMAharesinEUUKFranceGermanyItalySpainUKbasedondefineddailydosesDDDsFUTUREIMPACTSOFBIOSIMILARSBiosimilarswillcontinuetoimpactallaspectsofthehealthcaresystem,withsignificantimplicationsfromupcomingeventsExhibit25:KeybiosimilarimplicationsforstakeholdersacrossthehealthcaresystemPatientsInsurancecoverageandout-of-pocketcostsgPayersProvidersh BiosimilarcompaniesAssessingviableopportunitiesforbiosimilardevelopment(i.e.,ROI)Costvs.benefitofinterchangeabilityetAccessStrategyConsultingIQVIAInstituteDecttarsreturnon|33THISREPORTISBASEDONTHEIQVIASERVICESDETAILEDBELOWIQVIALONGITUDINALPRESCRIPTIONDATAclearinghousesrandqueplatformforassessingIQVIADRUGDISTRIBUTIONDATA(DDD)orSub-ondataproviders.IQVIA™PIPELINEINTELLIGENCEisadrugpipelineel