艾昆緯-美國(guó)生物仿制藥2023-2027 Biosimilars in the United States 2023–2027

Biosimilarsinthe

UnitedStates

2023–2027

COMPETITION,SAVINGS,ANDSUSTAINABILITY

JANUARY

2023

Introduction

ThefirstbiosimilarapprovedundertheabbreviatedpathwayestablishedbytheBiologicsPriceCompetitionandInnovationActlaunchedintheU.S.in2015,whilesomenon-originalbiologicshavebeenapprovedthroughotherpathwaysbothbeforeandsince.Despiteslowerinitialuptake,biosimilarlaunchesinthelastthreeyearshavegenerallybeenmoresuccessfulthanearlier,raisingimportantquestionsforupcomingbiosimilars,wheresavingsandpatientaccesscouldincreasesubstantially.

Inthisreport,thecurrentstateofthebiologicsmarketintheUnitedStatesandshareofthemarketfacingbiosimilarcompetitionareassessed.Factorsimpactingbiosimilaruptake,includingreimbursementandprovidertype,andtheimpactofbiosimilarsonmoleculevolumeandpriceareevaluated.Historicbiosimilartrendsareutilizedtoprovidepotentialfuturebiosimilarspendingandsavingsscenarios.

Weintendforthisreporttoprovideafoundationformeaningfuldiscussionaboutthevalueandroleofbiosimilarsoverthenextfiveyearsandthekeyimplicationsstakeholdersshouldconsiderasbudgetpressurescontinuetodrivehealthcaredecision-makingintheU.S.

ThisstudywasproducedindependentlybytheIQVIAInstituteforHumanDataScience,drawingonIQVIAproprietarydata.FundingforthisresearchandreporthasbeenprovidedbytheBiosimilarsCouncil,adivisionoftheAssociationforAccessibleMedicines.ThecontributionstothisreportofAllenCampbell,SarahMarkiewicz,UrvashiPorwal,VibhuTewary,TanushreeThakur,MarcellaVokey,andothersatIQVIAaregratefullyacknowledged.

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MURRAYAITKEN

ExecutiveDirector

IQVIAInstituteforHumanDataScience

?2023IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute.

BiosimilarsintheUnitedStates2023–2027:Competition,Savings,andSustainability

TableofContents

Overview2

Marketdynamicsandbiosimilardevelopment4

Factorsinfluencingbiosimilaruptake13

Biosimilarimpactsonmoleculevolumeandprice20

Futureimpactsofbiosimilars26

Notesonsources33

Definitionsandmethodology34

References35

Abouttheauthors36

AbouttheInstitute38

|3

BIOSIMILARIMPACTSONMOLECULEVOLUME

ANDPRICE

Theintroductionofbiosimilarsfrequentlyleadstohigherutilizationofthemoleculeaslowercostsofferincreasedaccesstopatients.Overtime,theutilizationofoldertreatmentssubjecttobiosimilarcompetitioncandecreaseasmoreinnovativealternativetreatmentsbecomeavailable.Patientaccesstosuccessivegenerationsoforiginatorproductshasnarrowedthemarketultimatelyaccessibletobiosimilars,impactingthepotentialfinancialreturnsforbiosimilardevelopers.

Introductionoflowercostbiosimilarsleadstodeclinesinoverallmoleculecostsperunit(i.e.,includesoriginatorandbiosimilars)atinvoicepricesovertime,typicallydrivingdowncostsfororiginatorsaswell.Absolutesavingsfrombiosimilarsvary,withlargersavingswhereoriginatorsweremorecostlyincludingthe2019biosimilarlaunches,whichhaveseenASPreductionsof$2,526–$4,913,potentiallyafactorintheirhighuptake.Off-invoicediscountsandrebateslikelyvarybyoriginatorandbiosimilarproducts,reducingthepricesexperiencedbypayers,patients,andotherhealthcaresystemparticipants.Pricereductionsandsavingsmaydifferwhenlookingatnetprices,includingdiscountsandrebates.

Themarketsharemaintainedbyoriginatorsafterfacingbiosimilarcompetitioniscorrelatedwiththerelativepricereductionintheoriginatorproductcomparedtothebiosimilar.Generally,originatorswhichhavereducedpricestosimilarlevelsasbiosimilarcompetitorshavelostlessvolumefollowingbiosimilarentry,whileoriginatorsmaintaininghigherpricesseesignificantvolumeloss.Asaresult,thehealthcaresystemtendstoseesavingsthroughuptakeoflowercostbiosimilarsand/orpricereductionsforthereferenceproduct.

FUTUREIMPACTSOFBIOSIMILARS

Futurebiosimilarsalesandsavingswilldependonavarietyofmarketdynamics.Tomodelthis,volumeuptakescenarioshavebeendevelopedincludinghigh,medium,andlow,tiedtobothoriginatorcompetitionandpricereductionsrangingfrom15–45%.

Expectedlaunchesanduptakearelikelytoincreaseoverallspendingonbiosimilarssignificantlyto$20–$49Bnin2027andcumulativesalesof$129Bnoverthenextfiveyears,withatleast10moleculesfacingbiosimilarcompetitionovertheperiod.Savingsoverthenextfiveyearsasaresultofbiosimilarsareprojectedtoexceed$180Bn,thoughuncertaintiesremainasmarketeventstodatesuggestawiderangeofmarketoutcomesarestillpossible.

Savingsasaresultofbiosimilarsareprojectedtoexceed$180Bnoverthenextfiveyears.

Theimmunologymarkethasseensignificantgrowthinbothspendingandvolumeinthelastfiveyears,andtheentryofnewimmunologybiosimilarsin2023willincreasecompetitioninthisrapidlygrowingmarket.Thebest-sellingbiopharmaceuticalintheU.S.,adalimumab(Humira),willfacebiosimilarcompetitionbeginningin2023,andproductcharacteristicsandreimbursementdecisionsarelikelytoimpactbiosimilaruptake.

WithbiosimilarsseeingincreasingacceptanceintheU.S.andthescaleofspendingonmedicinesfacingupcomingbiosimilarcompetitiongrowing,theimpactonallstakeholderswillbesignificant.

Marketdynamicsandbiosimilardevelopment

?TheU.S.biologicsmarkethasgrown12.5%annuallyonaverageoverthelastfiveyearsonan

invoice-pricebasis,fasterthannon-biologics,andnowcomprising46%ofspending.

?Moleculescurrentlyfacingbiosimilarcompetitiontotal$38Bnofinvoicespending,whileafurther$96Bnisthetargetofbiosimilarsindevelopmentorapprovedbutnotyetlaunched.

?Biosimilarslaunchedtodateaccountfor24%ofcompetitivemoleculevolume,and11%oftotalbiologicspendingatinvoicelevelsisfacingbiosimilarcompetition.

?Since2007,30biosimilarshavelaunchedacross

12moleculesintheU.S.,with10morebiosimilarsapprovedandsettolaunchbytheendof2023.

?TherearebiosimilarsapprovedorinclinicaldevelopmentintheU.S.for20moleculesinadditiontothe12withbiosimilarsalreadylaunched,withbiosimilarssettolaunchforthebest-sellingbiologicmolecule,adalimumab,in2023.

?Inthosemarketswithbiosimilars,competitivenessishighlyvariedbutbeingfirsttolaunchisgenerallyasignificantadvantage.

?Developmentofbiosimilarsisbeingdrivenbysmallercompanies,whilemarketingisdonemostlybylargecompanies.Inrecentyears,smallercompanieshavebegunmarketingmorebiosimilars,atrendthatisexpectedtocontinuewithupcomingbiosimilarlaunches.

Thebiologicsmarketcontinuestogrow,with14%ofthemarketfacingbiosimilarcompetition,anumberlikelytogrowby15%in2023asbiosimilarsareexpectedtolaunchformoleculeswithhighspending.

4|BiosimilarsintheUnitedStates2023–2027:Competition,Savings,andSustainability

|5

Biologics

CAGR2017-2021:

12.5%

TotalUSmedicines

CAGR2017-2021:

5.6%

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

TheU.S.biologicsmarketcontinuestogrowfasterthan

non-biologicsonaninvoice-basis,andnowcomprises46%ofspending

Exhibit1:TotalU.S.invoicespendinggrowthbytypeandleadingtherapyareasby2021spending,US$Bn

Leadingdrugclasses

Immunology90

Antidiabetics84

Oncology78

Respiratoryagents31Total2021USmedicine

Year-over-yearspendinggrowth

Antithrombotics27spending$568Bn

HIVantivirals26

Mentalhealth18

Multiplesclerosis17

Vaccines13

Pain12

SmallMolecule

54%

Biologic46%

Smallmolecule

CAGR2017-2021:

1.3%

16%

14%

12%

10%

8%

6%

4%

2%

0%

-2%

-4%

20172018201920202021

BiologicsSmallmoleculeTotalUSmedicines

Biosimilarsavailableaswellasindevelopment

Biosimilarsindevelopment

Source:IQVIAMIDAS,Dec2021;IQVIAInstitute,Nov2022.

?In2021,theUnitedStatesspent$568Bnonmedicinesatex-manufacturerinvoiceprices,including$260Bnonbiologics,whichnowcomprise46%oftotalmedicinespending.

?Evenincludingtheeffectofbiosimilarcompetitionoverthepastdecade,biologicsspendinghasincreasedsignificantlysince2017,atacompoundannualgrowthrate(CAGR)of12.5%,outpacingthe1.3%CAGRforsmallmoleculesandraisingthetotalmarketCAGRto5.6%.

?Thethreeclasseswiththehighestspending—immunology,antidiabetics,andoncology—accountfor70%ofbiologicsspending,andtheirbiologicsgrowthisat18.4%,12.3%,and14.8%CAGRs,respectively,inthepastfiveyears.

?Respiratoryagentshaveseensubstantialgrowthinbiologics,with19.7%CAGRsince2017duetoadvancesinsevereasthmatreatments.

?Severalbiosimilarlaunchesoccurredinthetopthreespendingareasinrecentyears,includingbiosimilarcancertreatments,insulins,andimmunologyagents.

?Additionalbiosimilarsareindevelopmentintheseclasses,aswellasinrespiratoryagents,antithrombotics,andmultiplesclerosisproducts.

?Smallerclassesofmedicines,suchasgrowthhormones,osteoporosistreatments,andocularanti-neovascularizationproductshavebiosimilarsavailable,withadditionalbiosimilarsindevelopment.

Notes:Oncologyincludestherapeuticagentsaswellassupportivecare.Invoicepricesinthisreportareex-manufacturerlevel,reflectingthepricesbetweenmanufacturersandtheircustomers(wholesalersordirectpurchasers),notincludingoff-invoicediscountsandrebates.

14%

Moleculeswithbiosimilarsindevelopment

$96Bn

53%

Biologicsmarket

$260Bn

70%

47%

Moleculeswithoutbiosimilarsindevelopment

$86Bn

16%

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

Moleculeswithbiosimilarstotal$38Bnofinvoicespending,whilebiosimilardevelopmentistargetingafurther$96Bn

Exhibit2:2021biologicsmarketsegmentedbystatusofbiosimilarcompetitionandbiosimilardevelopment

Moleculesfacingbiosimilarcompetition

$38Bn

Moleculeswithpotentialfuturebiosimilars

$181Bn

Non-recombinant/

vaccines

$41Bn

Source:IQVIAMIDAS,Dec2021;IQVIAPipelineIntelligence,IQVIAInstitute,Nov2022.

?Thecurrent$260Bnbiologicsmarketisalreadyfacingbiosimilarcompetition,withbiosimilarslaunchedfor12moleculesrepresenting14%($38Bn)ofbiologicspending(i.e.,exposedoriginatorsandtheirbiosimilarcompetitors).

?Anadditional16%ofthemarket,or$41Bn,arebiologicsproducedwithoutrecombinanttechnologies,suchaspurifiedorgatheredbiologics,therebymakingitimpossibletoproduceabiosimilar,thoughinsomecasesnon-recombinantbiologicsarealreadyfacinggenericcompetitionastheyarenaturallyoccurringsubstancesorvaccineswithoutpatentprotection.

?Theremaining70%or$181Bncouldfacebiosimilarcompetitioninthefuture.

?Justmorethanhalf(53%or$96Bn)ofthismarketcurrentlyhasbiosimilarsindevelopment,andtheremaining47%(or$86Bn)hasnobiosimilarscurrentlyindevelopment,withthesemoleculesvaryinginprotectionstatus(seeExhibit3).

Notes:Genericsfornon-recombinantbiologicsincludeglatirameracetate,enoxaparinsodium,andarangeofvaccinesandbloodplasmaproducts.Numbersmaynotsumduetorounding.

6|BiosimilarsintheUnitedStates2023–2027:Competition,Savings,andSustainability

|7

Originatorprotected

$89Bn

93%

Moleculeswithbiosimilarsindevelopment

$96B

Originatorunprotected

$7Bn

7%

Originatorprotected

$77Bn

90%

Moleculeswithoutbiosimilarsindevelopment

$86B

Originatorunprotected

$9Bn

10%

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

Mostofthemoleculeswithbiosimilarsindevelopmentcontinuetobeprotected,withonly7%unprotected

Exhibit3:2021biologicsmarketsegmentedbystatusofbiosimilardevelopmentandmarketexclusivity

21molecules

Avgsales=$4.2Bn

6molecules

Avgsales=$1.2Bn

145molecules

Avgsales=$532Mn

33molecules

Avgsales=$260Mn

Source:IQVIAMIDAS,Dec2021;IQVIAPipelineIntelligence,IQVIAInstitute,Nov2022.

?Thereare27moleculeswithbiosimilarsapprovedorinanystageofdevelopment:21wheretheoriginatorremainsprotectedbyexclusivityand

6thatareunprotected.

?The21moleculeswithbiosimilarsindevelopmentthatarestillprotectedgenerated$89Bninsalesin2021andaveraged$4.2Bn.Thisincludestheimmunologyblockbustersadalimumab(Humira)andustekinumab(Stelara),whichaccountedfor40%ofthisspending

andwillloseexclusivityin2023.

?Thesixunprotectedmoleculeswithbiosimilarsindevelopmentgenerated$7Bninsalesin2021andanaverageof$1.2Bn.Insulinaspart,whichlostpatentprotectionin2014,accountsfor$6Bnofthisspending,andabiosimilarhascompletedPhaseIIIintheU.S.Theremainingfivemoleculesaveraged$216Mninsales,withonebiosimilarindevelopmenteach.

?Thereare178moleculeswithoutbiosimilardevelopment,comprisingtheremaining$86Bn.The145moleculescurrentlyprotectedgenerated$77Bninspendingor$532Mnonaverage.Manyofthesearerecentlylaunchedandhavenotyetgeneratedbiosimilardevelopmentactivitybutmayinthefuture.

?Theremaining33withoutbiosimilardevelopmentareoff-patentandgenerated$9Bn,oranaverageof$260Mn,andarenotlikelytoseebiosimilardevelopmentactivityduetolowermarketpotentialforbiosimilarcompanies.

Notes:Protectedisdefinedashavinganexpirydateinthefuture,whileunprotectedisdefinedashavinganexpirydateinthepast.Numbersmaynotsumduetorounding.

Share

2015Q1

2015Q2

2015Q3

2015Q4

2016Q1

2016Q2

2016Q3

2016Q4

2017Q1

2017Q2

2017Q3

2017Q4

2018Q1

2018Q2

2018Q3

2018Q4

2019Q1

2019Q2

2019Q3

2019Q4

2020Q1

2020Q2

2020Q3

2020Q4

2021Q1

2021Q2

2021Q3

2021Q4

2022Q1

2022Q2

2022Q3

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

Biosimilarslaunchedtodateaccountfor24%ofcompetitivemoleculevolume

Exhibit4:Percentageofbiologicssalesaccessibletoapprovedandlaunchedbiosimilarsandbiosimilarefficiency,Q12015–Q32022

40%

35%

30%

25%

20%

15%

10%

5%

0%

Percentageofbiologicsmarketaccessibletobiosimilarsthatareapprovedbutnotyetlaunched(US$)Percentageofbiologicsmarketaccessibletolaunchedbiosimilars(US$)Biosimilarefficiency(DDDs)

Source:IQVIAMIDAS,Sep2022;IQVIAInstitute,Dec2022.

?Biologicsalescurrentlyaccessibletoandfacingbiosimilarcompetitionaccountfor11%oftotalbiologicsales,andbiosimilarefficiency—meaningthepercentagethatbiosimilarscompriseofaccessiblemoleculevolume—hasreached24%.

?Thepotentialsavingsthatbiosimilarsmaybringtohealthcarestakeholdersisoftendelayed,asiscompetition,sincetheapprovalofbiosimilarsdoesnotresultintheirimmediatelaunch.Delaysinavailabilityareoftenduetopatentlitigationandotherlogisticalissues.

?Biosimilarsthatareapprovedbutnotyetlaunchedrepresentanadditional13%oftotalbiologicsales,with10%fromadalimumab,whichhasbiosimilarslaunchingthisyear,and3%frometanercept,whichisnotexpectedtofacebiosimilarcompetitionuntil2029.

?Thelaunchofinsulinglargineandinfliximabbiosimilarsin2016resultedinasignificantriseintheaccessiblemarket—from2%to12%withinthefirstquarter—andreductioninbiosimilarefficiencyfrom19%to1%untiluptakeofbiosimilarsincreased.

Notes:Biosimilarefficiencymeasuresbiosimilarshareofmarketvolumewherebiosimilarsareapprovedandlaunchedandforthisexhibitiscalculatedbasedondefineddailydoses(DDDs)(seeDefinitionspage).

8|BiosimilarsintheUnitedStates2023–2027:Competition,Savings,andSustainability

|9

1

2

3

4

1

3

2

3

1

2

1

5

6

1

2

3

4

1

3

1

4

2

2

3

4

5

1

1

2

3

1

2

1

278

1

-

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

Since2007,30biosimilarshavelaunchedintheU.S.with10moreapprovedandsettolaunchbytheendof2023

Exhibit5:BiosimilarsapprovedandlaunchedintheU.S.

somatropin filgrastim infliximabinsulinglargine insulinlispro pegfilgrastim epoetinalfa bevacizumab trastuzumab rituximab teriparatide ranibizumabadalimumab

1

4

Jan-07Jan-13Jan-14Jan-15Jan-16Jan-17Jan-18Jan-19Jan-20Jan-21Jan-22Jan-23

LaunchedbiosimilarsApprovedbiosimilarsnotyetlaunchedLaunchnotannounced

Source:IQVIAInstitute,Dec2022.

?IntheUnitedStates,theBiologicsPriceCompetitionandInnovationAct(BPCIA)enactedin2010createdthe351(k)pathwayforbiosimilars,howeverthefirstbiosimilarwasnotapprovedthroughthispathwayuntil2015.Somebiosimilarswereapprovedthroughthe505(b)(2)pathwayforabbreviatedapprovalsofnon-originalproductsreferencinganotherproduct,andothersweresubmittedasanoriginalbiologicslicenseapplicationunderthe351(a)pathway.

?TheU.S.FDAhasapproved45biosimilarsacross14molecules(etanerceptnotshownabove)since2006,with30oftheseproductslaunchedand12moleculesfacingbiosimilarcompetitionasoftheendof2022.

?Bytheendof2023,atleast10ofthecurrentlyapprovedbiosimilarsareexpectedtolaunch,witheightofthesebeingbiosimilarsforadalimumab(Humira),whichwillloseexclusivityinJanuary2023.

?Generally,biosimilarsdistributedatpharmaciesrequireapprovalfromtheprescribertobesubstitutedforthereferenceproduct;however,theFDAgrantedinterchangeabilityforthefirsttimein2021toSemglee(insulinglargine),andsincethentwoadditionalbiosimilarshavereceivedinterchangeabilitystatuswithadditionalapplicationspendingwiththeFDA.Thisallowspharmaciststosubstitutebiosimilarswithoutgoingbacktotheprescriberforapproval.

?Althoughitisstillunclearhowinterchangeabilitywillimpacttheuseofbiosimilars,itallowspharmaciststomoreeasilysubstitutebiosimilarsfororiginatorproductssimilartohowtheyareabletosubstitutegenericsforbrands.

Notes:Biosimilarsapprovedbutnotyetlaunchedareplacedbasedonexpectedlaunchannouncedbycompany.Approvedetanercept(Enbrel)biosimilarsnotincludedastheyarenotexpectedtolaunchuntil2029.

adalimumab

insulinglargine

etanercept

epoetinalfa

infliximab

pegfilgrastim

rituximab

insulinaspart

insulinlispro

interferonbeta-1a

bevacizumab

ustekinumab

trastuzumab

aflibercept

liraglutide

pembrolizumab

somatropin

darbepoetinalfa

denosumab

ranibizumab

nivolumab

filgrastim

omalizumab

secukinumab

natalizumab

certolizumabpegol

golimumab

teriparatide

cetuximab

pertuzumab

ipilimumab

tocilizumab

peginterferonalfa-2a

follitropinalfa

eculizumab

ramucirumab

imiglucerase

pegaspargase

idursulfase

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

TherearebiosimilarsapprovedorinclinicaldevelopmentintheU.S.for20additionalmolecules

Exhibit6:Cumulativemoleculespendingandapproved,launchedandpipelinebiosimilarproductsforthemolecule

Cumulativespending1997–2021US$BnNumberofbiosimilardrugsbystatus

0255075100165-5051015

MoleculeswithlaunchedbiosimilarsMoleculeswithnolaunchedbiosimilars

Discontinued

Launched

ApprovedbutnotlaunchedPhaseItopre-reg

Pre-clinicaltodiscovery

Source:IQVIAMIDAS,Dec2021;IQVIAPipelineIntelligence,IQVIAInstitute,Dec2022.

?Currentlythereare39moleculeswithbiosimilarsapprovedorinthepipeline.Withinthese,30moleculeshavebiosimilarsinclinicaldevelopment(PhaseItopre-registration),12moleculeshavebiosimilarslaunched,andtwomoleculeshavebiosimilarsapprovedbutnotlaunched,astheyarestillpatent-protected.

?Biosimilarslaunchedthusfargenerallyhavebeenformoleculeswithsignificantlifetimespendingatinvoicelevels,withadalimumabandetanerceptbeingthetwolargestmoleculesbyspendingwithnobiosimilarcompetition,astheseproductsarestillprotected.

?Althoughinsulinshavegeneratedsignificantsalesatinvoicelevels,fewbiosimilarshavelaunchedorareindevelopmentforthesemolecules.Thisis,inpart,duetocomplexitiesofmanufacturinginsulinanddeepmarketdiscountsthatlimitpotentialfinancialreturns.

?Ninemoleculeswithbiosimilardevelopmenthaveattractedfiveormorebiosimilarcompetitors,whiletheremainingmoleculeshaveattractedfewer.

?Themagnitudeofmoleculesalesandthenumberofbiosimilarsindevelopmentisnotalwayscorrelated,ratheritappearsthattheselectionofmoleculesforbiosimilardevelopmentmaybeinfluencedbymultiplefactorssuchastechnicalcomplexityorintellectualpropertyissues.

?Onlytwomoleculeswithlessthan$1Bnincumulativesales,pegaspargase(Oncaspar)andidursulfase(Elaprase),havebiosimilarsindevelopment.Bothoftheseareindicatedforrarediseases,wheredifferentmarketdynamicsareatplaypotentiallyattractingbiosimilardevelopers.1

Notes:ForproductswithknownunderstatedsalesinIQVIAMIDAS,salesvaluesarereportedfrompublicsources.PipelineincludesbiosimilarmedicineswithdevelopmentprogramsintheUnitedStatesorotherdevelopedmarketswithregulatoryfilingsintheUnitedStatesorpubliclystatedintenttodoso.

10|BiosimilarsintheUnitedStates2023–2027:Competition,Savings,andSustainability

|11

Illustrative

ranibizumab

0.99

teriparatideepoetinalfa

0.690.61

Biosimilar1

Biosimilar2

Biosimilar5

Originator

MARKETDYNAMICSANDBIOSIMILARDEVELOPMENT

Formoleculesfacingbiosimilars,competitivenessishighlyvariedbutlargeshareforlatercompetitorsisrare

Exhibit7:MarketconcentrationHerfindahl-HirschmanIndexandsharesbycompetitorQ32022

Lowermarketconcentration

insulinlispro

0.86

insulinglargine

0.57

infliximab

0.42

bevacizumabsomatropin

0.380.33

trastuzumab

0.27

Highermarket

concentration

(manyand/

(Fewerand/

orsimilar

sizedcompetitors)

Illustrative

ordisparate

sizedcompetitors)

1.00.0

pegfilgrastimfilgrastim

0.380.34

Biosimilar3

rituximab

0.32

Biosimilar4

Source:IQVIAMIDAS,Sep2022;IQVIAInstitute,Dec2022.

?Asstakeholdersconsidertheimpactofbiosimilarcompetition,acommonmeasureofcompetitivenessinamarketistheHerfindahl-HirschmanIndex(HHI),whichassessesthenumberofcompetitors(includingtheoriginator)andthemarketshareeachachievestoprovideamorenuancedviewofmarketdynamics.

?Insustainablecompetitivemarkets,morecompetitorsdividethemarketmoreevenly,achievingalowHHIscore,whilemonopolieshaveascoreof1.0.

?Formoleculeswithbiosimilarcompetition,theirHHIscoresrangefrom0.27to0.99.Trastuzumabhasthelowestconcentrationofshareacrossthesixcompetitors,suggestingitiscurrentlythemostsustainablemarket.

?RanibizumabhasthehighestHHIscore,asbiosimilarsjustlaunchedinthemostrecentquarter.InsulinlisprohasthesecondhighestHHIscore(0.86),asthereisonlyonebiosimilarcompetitor,andtheoriginatorlaunchedanauthorizedgeneric,effectivelybluntingbiosimilaruptake.

?Todate,beingfirstorsecondtolaunchhasgenerallybeenasignificantadvantage.

?Inthefuture,especiallyinmedicineswithlargerspending,pricingim