全球制藥業(yè)生物仿制追趕

KeepingUpwiththeUpdatingOurBiosimilarDeepKeepingUpwiththeUpdatingOurBiosimilarDeepDive:Wepublisheda“biosimilardeepdive”noteinMay2018thatwaswell-receivedbyinvestorsandincludedasignificantamountofbackgroundinformationonthedevelopmentstatusofvariousbiosimilarsthataretargetingimportantblockbusterproducts.Giventherapidnewsflowinthebiosimilarspace,wearepublishinganupdatetoourdeepdivetodaythatincludesthelatestinformationaroundthestatusofvariousbiosimilars,alongwithadditionalthoughtsonhowtheregulatory,legalandpayerlandscapemayevolvetohelpcreateamorevibrantbiosimilarmarket,includingintheUS.Aug30,RESEARCHVamilDivan,vamil.divan@credit-Uyuy.ear@credit-MichaelV.Morabito,michael.morabito@credit-EuropeanPharmaRayray.kim@credit-NextWeek’sFDAPublicHearingShouldProvideImportantInsights:TheFDAhostinganall-daypublichearingonTuesday,todiscussCompetitionandInnovationintheBiologicalProductsMarketplace”(agenda).Wewillbelisteningcloselytothediscussiontounderstandtheperspectivevariousstakeholdershaveinthisdebate,althoughweseeclearmomentumbehindtheeffortstoboostbiosimilaradoptionintheUS.Novartis,Pfizer,MerckBestPositioned,WhileAbbVie,RocheAmongstMostatRisk:Novartis,PfizerandMerckallfaceriskofsaleserosionfrombiosimilarsinthecomingyears,buttheyarealsodevelopingtheirownbiosimilarsthatweexpecttohelpoffsetsomeofthatrisk.Ontheothersideofthespectrum,weseeAbbVieandRocheasthetwocompaniesmostexposedtobiosimilarriskgiventhethreattotheirblockbustersHumira(forAbbVie)andRituxan,HerceptinandAvastinforRoche.DISCLOSUREAPPENDIXATTHEBACKOFTHISREPORTCONTAINSIMPORTANTDISCLOSURES,ANALYSTCERTIFICATIONS,LEGALENTITYDISCLOSURETHESTATUSOFNON-USANALYSTS.USDisclosure:CreditSuissedoesandseekstodobusinesswithcompaniescoveredinitsresearchreports.Asaresult,investorsshouldbeawarethattheFirmmayhaveaconflictofinterestthatcouldaffecttheobjectivityofthisreport.Investorsshouldconsiderthisreportasonlyasinglefactorinmakingtheir每日每日免費(fèi)獲取報(bào)（增值服務(wù)關(guān)注公回復(fù)：研究報(bào)加入“起點(diǎn)財(cái)經(jīng)”微信群ExecutiveBiosimilarsFinallyExecutiveBiosimilarsFinallyPreparedtoMakeTheirTheauthorsofthisreportwishtoacknowledgethecontributionmadebySelvakumarNallasamyandBrajeshNirala,employeesofCRISILGlobalResearchandAnalytics,abusinessdivisionofCRISILLimited.CRISILLimitedisathird-partyproviderofoffshoreresearchservicestoCreditSuisse.2GreaterProportionofBrandedPrescriptionDrugSalesComingfromBiologicsandComplexMoleculesGlobalBrandedPrescriptionDrugSalesEstimatebyGreaterProportionofBrandedPrescriptionDrugSalesComingfromBiologicsandComplexMoleculesGlobalBrandedPrescriptionDrugSalesEstimatebyMolecule(Salesin$20102012201320142015201620172018201920202021SmallAnestimated~$115Bnof$293Bn(basedon2022sales)inannualglobalbiologicalsalesisexpectedtonolongerhavepatentprotectionby2023,leavingdoorwideopenforbiosimilarcompetition*Note:Throughouttheanalysesinthisnote,complexsmallmoleculedrugs(ex:Copaxone,InvegaSustenna)areclassifiedunderbiological3Source:CreditSuissePharmaValuesDatabaseandCreditSuisseBiosimilarsMarketNowintheMiddleInningsofaRobustPeriodofPatentExpiriesforBrandedBiologicProductsSalesDuringtheYearBeforePatentExpiryofBiologicsWhosePatentExpireby(YearofPatentExpiryinXaxis;PriorYearSalesin$BninYNotableNotable(Ex-US),NeulastaVictoza,StelaraUS)andEpogenLucentis(Ex-Ex-Note:NumbersintheparenthesesdenotethenumberofpatentexpiriesofNowintheMiddleInningsofaRobustPeriodofPatentExpiriesforBrandedBiologicProductsSalesDuringtheYearBeforePatentExpiryofBiologicsWhosePatentExpireby(YearofPatentExpiryinXaxis;PriorYearSalesin$BninYNotableNotable(Ex-US),NeulastaVictoza,StelaraUS)andEpogenLucentis(Ex-Ex-Note:Numbersintheparenthesesdenotethenumberofpatentexpiriesofblockbusterdrugs(sales4Source:CreditSuissePharmaValuesDatabaseandCreditSuisseNoofpatentexpiries,114338477115364Noofpatentexpiries,ex-21856104981267105BiosimilarsMarketRoche,AbbVieHaveMostAbsoluteSalesAtRiskfromBiologicPatentExpiries,WhileNovoandAbbVieHaveHighestPortionofSalesAtRisk2018AggregateSalesEstimateofProductsWhosePatentsExpiredorWillExpireby(Salesin$BnofTop15NovoEliShireNovartisProportion(%)of2018Roche,AbbVieHaveMostAbsoluteSalesAtRiskfromBiologicPatentExpiries,WhileNovoandAbbVieHaveHighestPortionofSalesAtRisk2018AggregateSalesEstimateofProductsWhosePatentsExpiredorWillExpireby(Salesin$BnofTop15NovoEliShireNovartisProportion(%)of2018SalesofProductsWhosePatentsExpiredorWillExpireby Eli BristolMerckNovartis 5Source:CreditSuissePharmaValuesDatabase,ThomsonEikon,FirstOrderAnalyticsandCreditSuisseBiosimilarsMarketBasedonCreditSuisseAnalysis,PFEStandstoBeaMajoroftheEvolvingBiosimilarPFEhasexclusiverightstothemajorityoftheirbiosimilarsoverthethreemajormarkets(US/EU/Japan)thathelpsthempotentiallybethebiggestbeneficiaryofallbiosimilarmakers–Majorityofplayersdevelopand/ormarketjointlywithpartnersthustheeconomicbenefitsaresharedamongmultipleplayersPresenceofmanynotablebrandedbiopharmacompanyinTop20listhighlightspotentiallylucrativenatureofbiosimilarmarketTop20BeneficiariesofBiosimilarMarketBasedonCSBasedonCreditSuisseAnalysis,PFEStandstoBeaMajoroftheEvolvingBiosimilarPFEhasexclusiverightstothemajorityoftheirbiosimilarsoverthethreemajormarkets(US/EU/Japan)thathelpsthempotentiallybethebiggestbeneficiaryofallbiosimilarmakers–Majorityofplayersdevelopand/ormarketjointlywithpartnersthustheeconomicbenefitsaresharedamongmultipleplayersPresenceofmanynotablebrandedbiopharmacompanyinTop20listhighlightspotentiallylucrativenatureofbiosimilarmarketTop20BeneficiariesofBiosimilarMarketBasedonCSAssignedKyowaHakkoMerck&Scoringmethodology:Foracompany,wehavegivenascoreof‘1’foreachofthethreemajorregions(US,EUandJapan)foreachbiosimilarinP2orabove.Iftherearemultiplepartnersforasinglebiosimilar,thescoreisdividedequallyamongthepartnersintherespectiveregions.Finallyaweightingof50/35/15isallocatedforUS/EU/JapantoarriveataggregatescorePlayershavingexclusiveeconomicrightsgetsahigherscoreandplayerswhosharetheeconomicbenefitsgetsalowerscorePlayershavingrightsacrossallthreemajorregionsgetthehighestCaveats:Wedonotfactorinthemarketsizeofeachbiosimilarandsoappliedequalweighttoallbiosimilars.Wealsolimitedouranalysistothetop12keybiosimilaropportunitiesdiscussedatthebackofthisslidedeckversusonlythetop10opportunitiesintheMayeditionofournote6Source:EvaluatePharmaandCreditSuisseEstimates&BiosimilarsMarketBlockbusterBiologicsBlockbusterBiologicsWherePotentialImpactofBiosimilarsBeingCloselyWatched,withMultipleUpdatesOverPastFewTNFstheKeyMarkettoWatchtoAssessBiosimilarAdoption,withRemicadeFirstUpRemicade(Salesin2020202120222023Biosims(probEnbrel(SalesinHumira(Salesin20152016201720192015201620172019202020212022Biosims(probBiosims(prob8Source:CreditSuissePharmaValuesAnti-TNFstheKeyMarkettoWatchtoAssessBiosimilarAdoption,withRemicadeFirstUpRemicade(Salesin2020202120222023Biosims(probEnbrel(SalesinHumira(Salesin20152016201720192015201620172019202020212022Biosims(probBiosims(prob8Source:CreditSuissePharmaValuesAnti-HumiraBiosimilarsAreExpectedintheEUinOct2018,WhileABBVIsSuccessfullyFendingOffCompetitionintheUSUntil2023FourHumirabiosimilars(inseventradenames)arealreadyapprovedintheEUandHumiraBiosimilarsAreExpectedintheEUinOct2018,WhileABBVIsSuccessfullyFendingOffCompetitionintheUSUntil2023FourHumirabiosimilars(inseventradenames)arealreadyapprovedintheEUandexpectedtobelaunchedinOct2018Severalothershavebeenfiled,settingupahighlycompetitivecommercialIntheUS,ABBVprotectsHumirawithanassortmentofpatentsthathasforcedatleastthreebiosimilarmakerstodatetosettlewithABBVandagreetonotlaunchtheirbiosimilarsuntil2023ABBVsettledwithAmgen,BiogenandMylanallowingthemtolaunchtheirbiosimilarsintheUSinWeexpectmoresuchsettlementsasbiosimilarmakersarepublicallyacknowledgingthedifficultyinovercomingABBV’spatentdefense,leadingustoassumewewillnotseeHumirabiosimilarsintheUSuntil2023From2018-2023,ConsensusestimatesHumirasalesgrowthinUSwilloffseterosioninCreditSuisseexpects2023WWHumirasalesof$16.4Bn($14.2BnUS,$2.2BnEx-US),from$18.4BninHumiraBiosimilarsinPhase2or(Salesin$ CS9Source:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& Momenta AYUMI/LG HumiraRemicadeBiosimilarsMadeStrongInroadsinEurope,WhileUSMarketHasRemainedElusiveMRKsawrapiderosioninRemicadeEuropesalesuponentryofLost~2/3salesinthreeyears,primarilyduetobiosimilarplayers’aggressiveRemicadeBiosimilarsMadeStrongInroadsinEurope,WhileUSMarketHasRemainedElusiveMRKsawrapiderosioninRemicadeEuropesalesuponentryofLost~2/3salesinthreeyears,primarilyduetobiosimilarplayers’aggressivepricediscounttowingovernmentMRK’sdefensestrategywastoholdontoasmanyexistingpatientsaspossibleasnewpatientswerestartingonbiosimilars,butreferencepricingdrovelowerpricesalongwiththelowervolumesIntheUS,JNJreported7%declineinsalesin2017andmid-teendeclinein1H2018afterPFElaunchedthefirstbiosimilarinNov2016JNJclaimedbiosimilarimpactduringthefirstyearwas‘farless’thanexpected.Thesalesdeclinesofarisprimarilyattributedtonegativepricingimpactasthevolumeremainsstableat94%asof2Q18CompanyexpectserosiontocontinuetoacceleratewithtwobiosimilarsnowintheJNJcontinuestobelievetheycanexpandtheiroverallimmunologyportfoliodespitetheimpactofbiosimilarRemicade,givenexpectedgrowthfromproductssuchasStelarainCrohn’sDiseaseandTremfyainpsoriasis(Salesin$RemicadeBiosimilarsinPhase2or$6.0$4.1$3.4CSSource:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& ABP RemicadeDeclineDespiteFairlyFewBiosimilarLaunches(Salesin$1Q15:InflectraSep'16:Flixabi/RenflexisRemicadeBrandedSalesRemicadeDeclineDespiteFairlyFewBiosimilarLaunches(Salesin$1Q15:InflectraSep'16:Flixabi/RenflexisRemicadeBrandedSalesRemicadeBiosimilarSales(Inflectra,Remsima&Source:Companydata,EvaluatePharmaandCreditSuisseEstimates&RemicadeEUEUInflectra(Celltrion&partners,launchedFeb-Zessly(Sandoz,approvedMay’18;launchestABP710(Amgen)–Launchest.2020(P3toplinereportedinJunFY2015(vs’14):-FY2016(vs’14):-47%;-29%FY2017(vs’14):-65%;-34%RemicadeEnbrelIsSlowlyConcedingtoBiosimilarsintheEU,WhileNovartisIsContestingAMGNintheUSCourttoLaunchtheFirstEnbrelBiosimilarEnbrelisexperiencinggradualerosionintheEUasreportedbyPFEEnbrelIsSlowlyConcedingtoBiosimilarsintheEU,WhileNovartisIsContestingAMGNintheUSCourttoLaunchtheFirstEnbrelBiosimilarEnbrelisexperiencinggradualerosionintheEUasreportedbyPFElost~1/3ofsalesinthetwoyearssincelaunchoffirstbiosimilarBenepaliinJan2016andareexpecting~15%salesdeclineperyearduetobiosimilarcompetitionPFEhastakenmandatorypricecutinsomeoftheEuropeancountriesafterthelaunchofEnbrelbiosimilarsandbelievethattheirnetpriceiscompetitivethepatenthurdleandsubsequentlylaunchthebiosimilarAMGNassertsvalidityoftwokeypatentsexpiringin2028and2029,whileConsensusassumehighsingledigitsaleserosionfrom2018onwardsNovartishasagreednottolaunchtheirbiosimilarandthetimelineofwhichisnotAMGNhasmovedforsummaryjudgementofinfringementandthetrialisnowscheduledforSep11,EnbrelWWConsensusSalesEstimates(Salesin$EnbrelBiosimilarsinPhase2orSource:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& AYUMI/LG Lupin/Yoshindo/Mylan/Biocon/YLB113 PhaseIII EnbrelEnbrelBrandedSalesHaveAlsoSeenaSharpDeclineOverPastTwoYearsDespiteRelativelyFewBiosimilarEntrantsMakingIttotheMarketEnbrelBrandvsBiosimilarSalesin(Salesin$Jun'17:ErelziEnbrelBrandedSalesEnbrelBrandedSalesHaveAlsoSeenaSharpDeclineOverPastTwoYearsDespiteRelativelyFewBiosimilarEntrantsMakingIttotheMarketEnbrelBrandvsBiosimilarSalesin(Salesin$Jun'17:ErelziEnbrelBrandedSalesEnbrelBiosimilarSalesSource:Companydata,EvaluatePharmaandCreditSuisseEstimates&EnbrelEUapprovals:EUfilings:Benepali(SamsungBioepis,Erelzi(Sandoz,JuneFY2016(vs’15):-FY2017(vs’15):-34%;-EnbrelLimitedDevelopmentofBiosimilarVersionsofStelaraPotentialPositiveforJNJ,butImpactLikelyStilltoBeFeltfromBiosimilarAnti-TNFsBasedonourreview,webelievetherearenoStelarabiosimilarsinmid-to-latestagesof–Therearethreeinpre-clinicaldevelopmentthatcouldemergeaspotentialcompetitorsafterStelara’spatentexpiresinSept2023intheUSandJan2024intheEUHowever,wewouldexpecttheentryofbiosimilarversionsofABBV’sHumirawillimpacttheimmunologyspaceasawholeandnegativelypressureStelarasalesstartingin2023,evenwithoutdirectbiosimilarStelaracompetitionStelaraWWSalesLimitedDevelopmentofBiosimilarVersionsofStelaraPotentialPositiveforJNJ,butImpactLikelyStilltoBeFeltfromBiosimilarAnti-TNFsBasedonourreview,webelievetherearenoStelarabiosimilarsinmid-to-latestagesof–Therearethreeinpre-clinicaldevelopmentthatcouldemergeaspotentialcompetitorsafterStelara’spatentexpiresinSept2023intheUSandJan2024intheEUHowever,wewouldexpecttheentryofbiosimilarversionsofABBV’sHumirawillimpacttheimmunologyspaceasawholeandnegativelypressureStelarasalesstartingin2023,evenwithoutdirectbiosimilarStelaracompetitionStelaraWWSales$6.4$6.2$6.0$4.9TherearethreeStelarabiosimilarsinpreclinicalresearchstageandwebelievenootherbiosimilarsinclinicaldevelopmentCSSource:EvaluatePharma,FirstOrderAnalytics,CompanydataandCreditSuisseEstimates&ModeratetosevereplaquepsoriasisSepActivepsoriaticarthritisSepModeratelytoseverelyactiveCrohn’sdiseaseSepModeratetosevereplaquepsoriasis(Ps)inOctStelaraBiosimilarsFarfromBeingaDirectThreattoOrencia,butAnti-TNFBiosimilarsLikelytoImpactOrenciaSalesasWellThoughOrencia’spatentsareexpiringby2021intheUSandEU,therearenobiosimilarsinactivedevelopmentsofarMomenta/MylanweredevelopingabiosimilarOrenciabutitfailedaPhase1pharmacokineticBiosimilarsFarfromBeingaDirectThreattoOrencia,butAnti-TNFBiosimilarsLikelytoImpactOrenciaSalesasWellThoughOrencia’spatentsareexpiringby2021intheUSandEU,therearenobiosimilarsinactivedevelopmentsofarMomenta/MylanweredevelopingabiosimilarOrenciabutitfailedaPhase1pharmacokineticCompanieshaveyettodisclosenextstepsonthisSimilartoStelara,webelievethatwhileOrenciamaybefreefromdirectbiosimilarcompetitioninthemid-term,brandedcompetitionandtheentryofbiosimilarversionsofanti-TNFdrugssuchasABBV’sHumirawillstarttopressureOrenciasalesTherearenoOrenciabiosimilarsinR&Dstage,thoughBioXpressTherapeuticsclaimsthattheyarepursuinganumberofbiosimilarcandidates,includingthatofabataceptCSSource:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates&OrenciaForRoche,RituxanFirstofThreeAssetstoFaceNear-TermEarlyTwoRituxanbiosimilarsapprovedinEuropeinFeb‘17(Celltrion)&Jun‘17(Sandoz).Significantpriceerosioninsomecountries(UK)FranchiseerosionhasacceleratedwithEUsalesdecliningYoY.CSassumeEURituxansaleswillerodeby-42%in2018and-40%in2019(3Q17:-6%,4Q17:-25%;1Q18:-44%;2Q18:-50%,25/75price/volumeTwofilingsinUS(2019LoE):CelltrionrefiledafterCRL;SandozreceivedRituximab/ObinutuzumabWWMarketCSforecastglobalsaleswillreduceby~65%by2022TheRocheForRoche,RituxanFirstofThreeAssetstoFaceNear-TermEarlyTwoRituxanbiosimilarsapprovedinEuropeinFeb‘17(Celltrion)&Jun‘17(Sandoz).Significantpriceerosioninsomecountries(UK)FranchiseerosionhasacceleratedwithEUsalesdecliningYoY.CSassumeEURituxansaleswillerodeby-42%in2018and-40%in2019(3Q17:-6%,4Q17:-25%;1Q18:-44%;2Q18:-50%,25/75price/volumeTwofilingsinUS(2019LoE):CelltrionrefiledafterCRL;SandozreceivedRituximab/ObinutuzumabWWMarketCSforecastglobalsaleswillreduceby~65%by2022TheRochedefense:EUteam,canyoupleaseTheSCformulationispricedatapremiumtotheIVformulationbutitsavestime&thereforemoneyforhealthcarewhichaimstopartiallyoffsetthecostdifferentialtoTheSCformulationhasbeenquitedurablesofaraccordingtoRocheandhashelpedtoslowsaleserosioninEurope,accordingtoRoche.Overallwebelievethattheformulationwillhelpdefendmarketshareuptoacertainlevelofpriceerosion,afterwhichusingtheSCformulationwillbeuneconomicalvscheapbiosimilars.USpenetrationoftheSCformulationislowerasphysicianshaveafinancialincentivetouseaninfusedproduct.AssuchitislesslikelytoprovidedefencetothefranchiseintheUS.updatingthis20152017201820192020202120222023Biosims(probRituxanbiosimilarlaunch-EU:Mid-2017US:GazyvaisRoche’sRituxanfollow-onproductwhichhasshownsuperioritydatatoRitxuaninsomeindications.CSassumesthatgrowthoftheproductwillaccelerateandhelptooffsetRituxanerosionglobally.CSassumesGazyvasalesof$1.8bnin2022.RituxanWWSalesCSSources:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& Celltrion/Teva/Purdue/Orion/Truxima NipponKayaku ABP FiveHerceptinBiosimilarsExpectedNearTerm,butPerjetatoProvideSomeSupporttoRoche’sHER2FranchiseHER2+targetingtherapyHerceptinisthesecondofRoche’skeybiologicstofacebiosimilarwithMercklaunchingabiosimilarcompetitorinEuropeinMarch2018.TwootherCSassumeEUHerceptinsaleswillerodeby-22%in2018andthiswillacceleratein2019(-35%)Weassumeupto5biosimilarswillbeapprovedinEuropebytheendof2019andbelieveerosionwilllikelybesteepforthefranchiseFiveHerceptinBiosimilarsExpectedNearTerm,butPerjetatoProvideSomeSupporttoRoche’sHER2FranchiseHER2+targetingtherapyHerceptinisthesecondofRoche’skeybiologicstofacebiosimilarwithMercklaunchingabiosimilarcompetitorinEuropeinMarch2018.TwootherCSassumeEUHerceptinsaleswillerodeby-22%in2018andthiswillacceleratein2019(-35%)Weassumeupto5biosimilarswillbeapprovedinEuropebytheendof2019andbelieveerosionwilllikelybesteepforthefranchise(SalesEUteam,canyoupleaseSimilartoRituxan,RochehastwoapproachestodefendtheHER2updatingthisSubcutaneousformulation:Formulationsavestime&thereforemoneyforHerceptingiventhehighnumberofbiosimilarsapprovedorneartomarket.PerjetahasbeenshowntoimprovesurvivalinHER2+breastcancerptswhencombinedwithHerceptin/chemo.RochewillonlysellPerjetaincombinationwithbrandedHerceptin.PerjetawillbecriticalinoffsettingsalesgreaterdefenceintheUSwherereimbursementshouldbelesschallengingvsEU20152016201720182019202020222023Biosims(probHerceptinbiosimilarlaunch-EU:1Q-2018;US:CSe HerceptinWWSales$6.8HerceptinBiosimilarsinPhase2or$4.7$4.0CSSources:EvaluatePharma,CSestimates,company Celltrion/Teva/Purdue/NipponHerzuma Allergan/Amgen/Daiichi/Synthon PhasePrestige AvastintheLastoftheThreeKeyRocheFranchisestoFaceBevacizumabMarketCSassumesthatAvastinwillbethelastofRoche’sdrugsto(SalesWeexpectatleastoneAvastinbiosimilartolaunchinEuropein2019(Amgenapproved)althoughcompetitionwilllikelyincreasewithanumberofbiosimilarsassets(seebelow)inphase3studies(CSassumesEUAvastinsaleswillerode-10%in2019,-40%in2020).IntheUSAmgen’sbiosimilarhasalsobeenapproved,withpotentiallaunchinJuly2019.However,ongoinglitigationhasCSexpectAvastinglobalsalestoreducebyc55%byAvastintheLastoftheThreeKeyRocheFranchisestoFaceBevacizumabMarketCSassumesthatAvastinwillbethelastofRoche’sdrugsto(SalesWeexpectatleastoneAvastinbiosimilartolaunchinEuropein2019(Amgenapproved)althoughcompetitionwilllikelyincreasewithanumberofbiosimilarsassets(seebelow)inphase3studies(CSassumesEUAvastinsaleswillerode-10%in2019,-40%in2020).IntheUSAmgen’sbiosimilarhasalsobeenapproved,withpotentiallaunchinJuly2019.However,ongoinglitigationhasCSexpectAvastinglobalsalestoreducebyc55%by2015201720182020202120222023Biosims(probAvastinbiosimilarlaunch-EU:CSe2019;US:CSec.July AvastinWWSalesAvastinBiosimilarsinPhase2orCSSources:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& BI Insud AMGNIsPreparedtoFaceNeulastaBiosimilarCompetitionWellinAdvancewithItsOn-BodyInjectorDeviceAMGNexpectspotentialbiosimilarcompetitiontoentertheUSmarketin2H2018andthesameisAMGNIsPreparedtoFaceNeulastaBiosimilarCompetitionWellinAdvancewithItsOn-BodyInjectorDeviceAMGNexpectspotentialbiosimilarcompetitiontoentertheUSmarketin2H2018andthesameisreflectedintheir2018financialguidanceInanefforttoprotectNeulastasalesfrombiosimilarcompetition,AMGNlaunchedNeulastaOnprokit,anon-bodyinjectordeviceLaunchedintheUSinAug2015andasof2Q18accountsfor63%ofthetotalNeulastaunitssoldintheApprovedintheEUin2Q18andalreadylaunchedinsomeoftheEuropeancountriesasthecompanyexpectstoconvertNeulastapatientsinthenewmarketstothenewOnprokitWebelievepatentsonthedevicecouldextendouttothe2030+BiosimilarmanufactureslookingtolaunchabiosimilarNeulastamayneedtonavigatearoundpatentsonthedeviceorendupofferingaproductthatisadministeredinalessattractivemannerNeulastaWWConsensusSales(Salesin$NeulastaBiosimilarsinPhase2orSource:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& NeulastaLantusAlreadyExperiencingaSignificantDeclineDuetoBiosimilarCompetition,withMoreLikelytoComeInsulinglargineMarketSalesAtitspeakLantus,generatedsalesofover$8bnin2014($5.6bninUS)(Salesin$Sanofihasanext-generationhighdoseversionofLantus(Toujeo),theproductisexpectedtogeneratesignificantlylowerpeakrevenues(CSassumes$1.3bn)ThebasalinsulincategoryhasseenpricingpressurefollowingofbiosimilarsFDAin2015andlaunchedin2016USsalesofLantushavehalvedsince2014to$2.8Bnin201520172018LantusAlreadyExperiencingaSignificantDeclineDuetoBiosimilarCompetition,withMoreLikelytoComeInsulinglargineMarketSalesAtitspeakLantus,generatedsalesofover$8bnin2014($5.6bninUS)(Salesin$Sanofihasanext-generationhighdoseversionofLantus(Toujeo),theproductisexpectedtogeneratesignificantlylowerpeakrevenues(CSassumes$1.3bn)ThebasalinsulincategoryhasseenpricingpressurefollowingofbiosimilarsFDAin2015andlaunchedin2016USsalesofLantushavehalvedsince2014to$2.8Bnin201520172018201920202023LantusUSLantusROWToujeoUSToujeoROWBiosims(probErosionofUSLantussalesisexpectedtoacceleratein2018followingtheinclusionofBasaglaronMedicarePartD(Salesin$GoingforwardwealsoexpectthelaunchofMerck’sbiosimilarLusdunain2019,whichwilllikelyaccelerateerosionfurtherLantusBiosimilarsinPhase2orCSSources:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& Eli Gan&Lee PhaseLantusVictozaNowNovo’sLargestProduct,withBiosimilarPossibleinVictoza(once-weeklyGLP-1)haspeaksalesofNovolookingtoswitchpatientstoitsnext-generationGLP1Ozempic(weeklydosed)priortopatentexpiryforVictoza(2022/23)Novolog/NovorapidConsensusSales(Salesin$InFeb2017,TevahasfiledanANDAforVictozaintheUSandchallengedthepatentvalidity.NovopetitionedtheFDAarguingthatliraglutideisacomplexmoleculeandgenericsshouldnotbeapprovedwithoutclinicalstudiesprovingsafetyandefficacysimilartoliraglutide,whichwasdeniedbytheFDANovolog/NovoRapidhaspeaksalesofCSVictozaNowNovo’sLargestProduct,withBiosimilarPossibleinVictoza(once-weeklyGLP-1)haspeaksalesofNovolookingtoswitchpatientstoitsnext-generationGLP1Ozempic(weeklydosed)priortopatentexpiryforVictoza(2022/23)Novolog/NovorapidConsensusSales(Salesin$InFeb2017,TevahasfiledanANDAforVictozaintheUSandchallengedthepatentvalidity.NovopetitionedtheFDAarguingthatliraglutideisacomplexmoleculeandgenericsshouldnotbeapprovedwithoutclinicalstudiesprovingsafetyandefficacysimilartoliraglutide,whichwasdeniedbytheFDANovolog/NovoRapidhaspeaksalesofCSSanofiiscurrentlydevelopingabiosimilar(SAR341402)whichhasbeenstudiedinPhase3trialsVictozaWWSalesThefutureapprovalofSanofi’sSAR341402isunclearwiththeUSstrategy“underreview”.VictozaBiosimilarsinPhase2orNovologBiosimilarsinPhase2orCSSource:EvaluatePharma,BLOOMBERGPROFESSIONALTMservice,CompanydataandCreditSuisseEstimates& TevaPharmaceutical Victoza&NovologHealthcareLandscapeHealthcareLandscapeEvolvingRapidly,withIncreasedFocusonRoleBiosimilarsCanPlayinManagingDrugAdvancingBiosimilarsFDACommissionerScottGottliebAdvancingBiosimilarsFDACommissionerScottGottliebhasrepeatedlystatedtheagency’scommitmenttoadvancingbiosimilars–Gottlieb’sMar2018speechtoAmericanHealthInsurancePlans(AHIP)inparticularstressedtheneedforFDAtosupportbiosimilardevelopment,includingthefollowingtellingstatements:“Accesstomedicinesisamatterofpublic“Robustcompetitionexpandspatientaccesstomoreaffordableproductslikegenericsand“Economicsof[biosimilar]developmentarecurrentlyunstable;We’recommittedtoadvancingpoliciesthathelpmakethatprocessmore“Biosimilarsnotonlypresentopportunitiesforsignificantcostsavings,theycandramaticallyexpandpatientaccesstotherapies”“MillionsofAmericanpatientsstandtobenefitfromincreasedutilizationoflower-cost,highqualitybiosimilarproducts”“FDAisinvestedinmakingsure…thenewbiosimilarpathwayworks,andthatwecanhelpfacilitatearobustmarketforthese“WecontinuetoseeabacklashagainsttheseKabukidrug-pricingconstructs--constructsthatobscureprofittakingacrossthesupplychainthatdrivesupcosts”“Wemustdomoretoensure…currentpipelineofbiosimilarproductsreachespatientsassafelyandefficientlyaspossible,andthatthefullpotentialofbiosimilarproductstoimprovepatienthealthisrealizedonceproductsmeettheFDA’shighstandardsforapproval”“Craftingpolicyoptionsthatcanimprovecompetition,access,andthechanceforpatientstobenefitfromsafe,effective,andlowercostbiosimilaralternatives”“WehopetohavemuchmoretosayonthisplansoonasweunveilourcomprehensiveapproachinourBiosimilarAccess“FDAwilldoitspartbylayingoutanefficientpathforshowinghowbiosimilarproductscandemonstrateinterchangeabilitywiththeirbrandedcounterparts”“We’llknowwe’vebeensuccessfulwhenthere’sabiosimilarmarketthatcansustainmultiplecompetingbiosimilarandbiologicSource:FDAandTheCenterforBiosimilars,CreditSuisseFDAHasWithdrawnDraftGuidanceonFDAHasWithdrawnDraftGuidanceonAnalyticalSimilarity,butwithUltimateGoalof