2022年生物仿制藥報(bào)告（英）-英

202

2BiosimilarsRepor

t:The

U.S.

Journey

andPath

AheadINTRODUCTIONWelcome

to

our

2022

BiosimilarsReport:

The

U.S.

Journey

andPath

AheadTable

ofcontents?

Biosimilars

101Cardinal

Healthisfortunate

to

sitatthecrossroads

oftheUnited

States

(U.S.)

healthcaresystem,

engaging

withstakeholders

from

across

theindustry

includinghealthcareproviders,

healthsystems,

pharmaceutical

andmedicalproductmanufacturers,pharmacists,payers

andpolicy

makers

to

support

thedelivery

ofessentialcare

tothemostimportant

stakeholder

–

patients.

This

vantagepointhasgiven

usa

uniqueperspectiveontheimportantrole

ofbiosimilarsintheU.S.

healthcare

landscapeandthepotential

bene?tsthey

may

deliver

to

patientsandthehealthcare

system

atlarge.?

2021

BiosimilarsLandscape?FDA

ApprovedBiosimilars?Overall

U.S.BiosimilarsMarket

ShareSincethe?rstbiosimilarwasapproved

intheU.S.

in2015,we

have

taken

anactive

roleinsupporting

theuseoftheseproducts–

notonlyby

distributing

themto

healthcareproviders

andworking

withmanufacturersto

bring

new

biosimilarsto

market,

butalsothrough

extensiveresearch

andeducationalinitiatives

designed

to

builda

betterunderstandingofhow

biosimilarsmay

contributeto

high-quality,lower-costcare.?BiosimilarsAdoption

RatesIn

this,

our?rst-ever

Biosimilars

Report:

The

U.S.

Journey

and

Path

Ahead,

we

haveaspired

to

bring

together

thelatest

industry

dataonutilizationandpayer

coverage

withourown

research

andperspectivesfrom

leadingexperts

onwhere

biosimilaradoptionstandstoday

intheU.S.,

andwhatwe

canexpect

in2022andbeyond.

We

are

pleasedto

includeviews

from

ourinternalexperts

andtop

physicians

inkey

therapeuticareaswhere

biosimilars

are

making

an

impact.

The

report

also

features

results

from

our

researchwithhealthcare

providers,

whichincludessurveys

withmore

than320oncologists,

100rheumatologists,

100retina

specialists,

50endocrinologistsandprimary

care

physicianstreating

diabetes,

and115pharmacists.?

Provider

Trends????OncologyRheumatologyOphthalmologyDiabetes?

Payer

TrendsThe

future

ofbiosimilarsintheU.S.

isexciting

–

notonlybecauseoftheirpotential

tolower

thecostsofbiologic

medicinesandto

makecare

more

accessibleto

patients,

butalsobecausethey

willcreate

spacefor

new

innovations

andscienti?cbreakthroughs.As

we

move

forward

in2022,enablingnew

advancementsincare

andbetter

accessforpatientsare

goalsthatallhealthcarestakeholders

shouldbealigned

on.

We

lookforwardto

collaboratingwithourcustomers,

partners

andindustry

colleaguesonthesee?orts.?

Five

BiosimilarsPredictionsfor

2022Wishing

you

goodhealthin2022!Sincerely,Victor

CrawfordCEO,

PharmaceuticalSegmentCardinalHealth23BIOSIMILARS

101"Industry

analystssay

that

biosimilarsare

on

track

toreduce

U.S.

drugexpenditure

by$133

billionA

Biosimilars

Primer:by

2025."Medications

T

hat

DriveCompetition,

Lower

Cost

sand

Increase

Accessibilit

yAlthough

the

?rst

biosimilarwas

approvedby

theU.S.

Food

and

Drug

Administration(FDA)nearly

seven

years

ago,

thisclassofproductsis

stillnewto

many

whowork

in

healthcare,particularly

intherapeutic

categoriessuch

asdiabetesand

ophthalmology

where

biosimilarshave

received

approval

only

recently.

Thefollowingis

a

primerof

thekey

terms

andfactsrelated

to

biosimilars.activeingredientsasbrandnamedrugs,biologicsarelarge,complexmoleculesthataremanufacturedfromlivingcells,whichresultsininherentvariabilityassociatedwiththem.

Therefore,whereagenericmustdemonstratebioequivalencetothebranddrug,biosimilarsmustdemonstratetheyarehighlysimilartothereferenceproduct—thustheterm“biosimilar.”whentheBiologicsPriceCompetitionandInnovationActwasenactedin2010,whichestablishedanabbreviatedpathwaytoFDAapprovalforbiosimilarsundersection351K,withtheaimofenablinggreaterpatientaccesstolower-cost,high-qualityproducts.Theapprovalprocessrequiresbiosimilarmanufacturersto

submitdatathatdemonstratesthereisnoclinicallymeaningfuldi?erencefromthereferencebiologic.Althoughtheapprovalpathwayfor

biosimilarsisabbreviated,theFDA

requiresbiosimilarsto

meetequallyrigorousapprovalstandards,whichmeanspatientsandhealthcareprofessionalscanbeassuredoftheirsafety,

e?cacyandquality–

justastheywouldthereferenceproducts.In

theU.S.,biosimilarsarecurrentlyusedtotreatpatientswithcancers,kidneydiseases,diabetes,andotherautoimmunediseasessuchasrheumatoidarthritisandCrohn'sdisease.What

is

a

biosimilar

and

how

does

itcompare

to

a

generic??

Biosimilartreatment

optionsare

proven

to

bejustassafe

ande?ective

asoriginator

biologics.Abiosimilarisabiologictreatment(i.e.,madefromlivingcells)thatisjustassafeande?ectiveasanexistingFDA-approvedbiologic,alsoreferredtoasthe“referenceproduct.”Unlikegenerics,whicharemanufacturedfromsmall-molecule,chemicalcompoundsandhavethesame?

Biosimilarsare

approved

through

anabbreviated

FDA

pathway,

withthegoalofHow

are

biosimilars

reviewed

andapproved

by

the

FDA?expanding

patient

access

to

high-quality,

lower-cost

care.?

As

ofJanuary

2022,there

are

33FDA

approved

biosimilarsintheU.S.,

21ofwhichareBiosimilaradvancementsintheU.S.begancommercially

available

onthemarket.45BIOSIMILARS

101BIOSIMILARS

101How

many

biosimilars

are

on

themarket

in

the

U.S.?Acommonmisconceptionisthatinterchangeablebiosimilarsmustofbiosimilarsleads

to

greater

competition,thereby

lowering

costs

and

increasingaccessibility

and

a?ordability

of

thesecritical

treatments.

Industry

analysts

saythat

biosimilars

are

on

track

to

reduce

U.S.?nancialconsiderations,continuedknowledgegapsamongsomekeymeethigherstandardsforapprovalthannon-interchangeablebiosimilars.However,

allbiosimilars—whetherinterchangeableornot—undergorigorousandthoroughevaluationstoensuresafetyande?ectivenessinordertomeettheFDA’s

highstandardsforapproval.Interchangeabilitydesignationisobtainedthroughthesubmissionofadditionaldata,generallyintheformofswitchingstudies,toassessthesafetyofswitchingbetweenareferenceproductandbiosimilarmultipletimes.stakeholders(includingprovidersandpatients)regardingbiosimilarscanbeabarriertoadoption.

ThelackoffamiliaritywithbiosimilarscontributestohesitancieswiththeseproductsandisakeydriverbehindrecentcongressionalandFDAactivities,includingthepassageoftheAdvancingEducationonBiosimilarsActof2021,intendedtoincreaseeducationandawarenessamongproviders.AsofJanuary2022,thereare33FDA-approvedbiosimilars,21ofwhichareavailableontheU.S.market.

Ten

ofthe33productshavedelayedlaunchesprimarilyduetopatentlitigationbetweenthereferencebiologicandbiosimilarscompanies.Of

the21biosimilarsonthemarket,17areusedfortreatmentsassociatedwithcancers,threeareusedtotreatautoimmuneconditionsandoneisusedtotreatdiabetes(SeeFigure1forfulldetails).drug

expenditure

by

$133

billionby2025.2TheU.S.isalreadyseeinghowbiosimilarsarereducingcosts:In2020alone,biosimilarssaved$7.9billion(morethantriplethe$2.5billionsavedthepreviousyear),withsavingsexpectedtogrowsigni?cantlyinthenextfewyearsasmorebiosimilarsenterthemarket.3What

resources

are

available

to

providefurther

information

on

biosimilars?If

biosimilars

are

more

a?ordable,

whyare

they

not

more

widely

used?What

does

“interchangeability”

meanand

why

is

it

important?ThosewhowishtolearnmoreaboutbiosimilarscanexploretheFDA'sWhy

are

biosimilars

important

to

theU.S.

healthcare

system?TheU.S.healthcaremarketiscomplex,particularlythepayerdynamicsthatdictatehowdrugsarereimbursed.Althoughbiosimilarsaregenerallypricedlower,

stakeholderincentivesarenotalwaysalignedtoenableorsupportbiosimilaradoption.InadditiontotheBiosimilarswebsite,whichincludesawealthofeducationalmaterial,andthe“PurpleBook,”

whichistheo?cialdatabaseforallFDA-licensedbiologicalproductsincludingreferencebiologics,biosimilarsandinterchangeablebiosimilars.Inaddition,CardinalHealthhaseducationalresources,thoughtleadershipandafull

listing

of

available

biosimilars,aswellasaninteractivetoolthatcanbeusedtolookupstate

laws

related

tointerchangeability.InterchangeabilityisaregulatorydesignationforbiosimilarsthatisuniquetotheU.S.

Thedesignationallows“pharmacist-levelsubstitution,”meaningthatapharmacistcansubstitutethereferencebiologicwithabiosimilarperstatelaws,withoutconsultingwiththeprescribingphysician.

Thisissimilartohowpharmacistsroutinelysubstitutegenericdrugsforbrandnamedrugstoday.

For

biosimilarsdispensedattheretailpharmacyand/orcoveredunderthepatient’spharmacybene?t(suchasinsulinandHumirabiosimilars),theinterchangeabilitydesignationisimportantbecauseitwillenablepharmaciststohelpfacilitatepatientaccesstohigh-qualitytreatmentoptionsatthelowestcost.Biologics

are

among

the

most

expensivemedicines

inthe

U.S.—

some

with

coststotaling

tens

ofthousandsofdollarseachyear

perpatient.

Biosimilarsareexpectedto

bepriced

15%

to

30%

lower

thantheirreference

products.

Themarket

entrance1“Biosimilars

—

whether

interchangeable

or

not

—undergo

rigorous

and

thorough

evaluations

toensure

safety

and

e?ectiveness

in

order

to

meetthe

F

DA’s

high

standards

for

approval."672021

BIOSIMILARS

LANDSCAPE"The

promiseof

biosimilarshas

started

tobecome

a

reality,as

greatercompetition

...is

beginning

todrive

meaningfulcost

savings."2

021BiosimilarsLandscape2

021:

AYear

of

Milestones

andProgress

for

Biosimilars

in

the

U.S.“By

promoting

negotiation,competitionandinnovation

inthehealthcare

industry,

we

willensure

costfairness

andprotect

accessto

care.”To

begina

re?ection

of

2021biosimilarsactivity,I

cannot

helpbut

to

thinkback

towhenI

?rst

beganworking

in

biosimilarsand

U.S.

national

strategies

over

?ve

yearsago.My

passionfor

thisspace

grewquicklyas

I

saw

how

healthcare

organizations,

andmoreimportantly

patients,

continued

tograpple

with

therising

healthcare

costsassociatedwith

critical

biologics.thelaunchof

the?rstbiosimilarin

2015,we

now

have33FDA

approvedbiosimilarswith

21

available

onthe

market

as

ofJanuary

2022.

The

U.S.biosimilars

storythat

was

initiallydescribed

assluggishanddelayed

hasnow

transformed

toone

ofprogress

and

momentum.

Thispast

year,thepromise

of

biosimilarshasstarted

tobecomea

reality,

as

greater

competition

forsomeofthe

costliest

biologic

treatmentson

themarketis

beginning

to

drivemeaningful

cost

savings.Sonia

T.

Oskouei,PharmDVicePresident,BiosimilarsCardinalHealth-

U.S.

Department

of

Health

and

Human

ServicesSecretary

XavierBecerra4Fast

forward

to

today,

andI

amdeeplyencouraged

by

theprogressmadeintheU.S.,

especially

thispast

year.

Following892021

BIOSIMILARS

LANDSCAPE2021

BIOSIMILARS

LANDSCAPEFigure

1.FDA

approved

biosimilarsSigni?cant

progress

has

beenmadein

the

adoptionofbiosimilars

in

theU.S.,particularly

inoncology,

where

allthree

classesoftherapeutic

oncologybiosimilars

(i.e.,

rituximab,

bevacizumab,andtrastuzumab)

have

exceeded

60%market

share(See

Figure

2).

Savings

frombiosimilars

increased

to

approximately

$8billionin2020alone,

more

thantriplingsavings

derived

from

previous

years.Inaddition,for

the?rsttime

in

seven

years,oncology

expenditure

growth

fell

below10%due

tothe

impact

ofbiosimilars

andReference

Product(molecule)

—

CompanyBiosimilarProduct(s)BiosimilarCompany(Estimated)Launch

DateReference

Product(molecule)

—

CompanyBiosimilarProduct(s)BiosimilarCompany(Estimated)Launch

DateMvasiAmgenP?zerJuly2019Jan.2020Lucentis(ranibizumab)—

GenentechAvastin(bevacizumab)—

GenentechByoovizBiogenJune2022ZirabevBasaglarSemglee*RezvoglarEliLillyViatrisEliLillyDec.2016Aug.2020TBDEpogen/Procrit(epoetinalfa)—

Amgen/JanssenRetacritP?zerNov.2018Lantus(insulinglargine)—

Sano?EticovoErelziSamsungSandozAmgenViatris2029newproduct

launches.5Enbrel(etanercept)—

AmgenAlthough2021brought

fewermarketentrantsthan

previous

years,

itwas

stilloneof

the

most

eventful

years

in

U.S.biosimilars

history.

Several

key

milestoneswere

achieved

thispastyear,

and

thefollowing

representjust

a

fewworthhighlighting:2029FulphilaUdenycaZiextenzoNyvepriaViatrisCoherusSandozP?zerJuly2018Jan.2019Dec.2019Dec.2020KanjintiOgriviJuly2019Dec.2019Feb.2020Mar.2020May2020Neulasta(peg?lgrastim)—

AmgenHerceptin(trastuzumab)—

GenentechTrazimeraHerzumaOntruzantP?zerTevaNivestymGranixP?zerTevaOct.

2018Nov.2013Sept.

2015The

?rst

interchangeable

biosimilarwas

approved

in

the

U.S.Neupogen(?lgrastim)—

AmgenOrganonIn

July2021,the

FDAmade

a

landmarkdecisionto

approve

the?rstZarxioSandozAmjevitaHadlimaAmgenJan.2023June2023interchangeablebiosimilarintheU.S.

forViatris’Semglee

(insulinglargine-yfgn),referencingthelong-acting

insulin,Lantus.

The

approval

was

signi?cant

foramultitude

of

reasons:Notonly

isSemgleethe?rstinterchangeable

biosimilar,

butthe?rstbiosimilar

indiabetes

care,

and

the?rst

biosimilar

that

isprimarilydispensedat

retailpharmacies;

therefore,

it's

billedunderthepharmacy

bene?t.In?ectraRen?exisAvsolaP?zerOrganonAmgenNov.2016July2017July2020OrganonRemicade(in?iximab)—

Janssen**BoehringerIngelheimCyltezo*July2023HumiraYusimryHulioCoherusViatrisJuly2023July2023Sept.

2023Nov.2023(adalimumab)—

AbbVieTruximaRuxienceRiabniTevaP?zerNov.2019Feb.2020Jan.2021Rituxan(rituximab)

—

GenentechHyrimozAbriladaSandozP?zerAmgenBiosimilarstobelaunched;allothersarecurrentlymarketed.Biologicsthatarenottruebiosimilarsandwere

approvedundereitherthe351(a)or505(b)(2)pathways."Increasing

competition

through

the

introduction

of

biosimilarscreates

opportunity

to

decrease

the

?nancial

burden

associatedwith

these

products,

which

in

turn

could

reduce

the

risk

for

negativeoutcomes

due

to

medication

nonadherence."Source:U.S.Food&DrugAdministration.Retrievedfrom:/drugs/biosimilars/biosimilar-product-information.*SemgleegainedFDAapprovalasaninterchangeablebiosimilaronJuly28,2021,andCyltezogainedaninterchangeabilitydesignationinOctober2021.**Ixi?(P?zer’sotherRemicadebiosimilar)hasnoplanstolaunchintheU.S.10112021

BIOSIMILARS

LANDSCAPE2021

BIOSIMILARS

LANDSCAPEFigure

2.Overall

U.S.

biosimilars

market

shareCurrent

Number

ofBiosimilar

CompetitorsBiosimilar

MarketShare

(Sept.

2021)ProductCategory1st

Biosimilar

LaunchNeupogen(?lgrastim)Remicade(in?iximab)Epogen/Procrit

(epoetinalfa)Neulasta(peg?lgrastim)Avastin

(bevacizumab)Herceptin

(trastuzumab)Rituxan

(rituximab)Supportive

CareImmunologySupportiveCareSupportiveCareOncology201520162*389%32%52%38%**74%60%64%3%201812018420192Oncology20195Oncology20193Lantus

(insulinglargine)8

Product

ClassesDiabetes2020***1***21Source:IQVIA:AccessedviaIQVIANationalSalesPerspective(NSP)SMARTData.(October2021).*ExcludesGranix.**NeulastaSyr.onlybiosimilarsmarketshareis75%.***ExcludesBasaglar.IncludesSemglee,whichtransitionedtoaninterchangeablebiosimilarinJuly2021.This

approval

hassigni?cantopportunity

toexpand

lifesaving

treatment

optionsfor

themillionsofinsulin-dependent

Americanslivingwithdiabetes.

Despiteitsdiscoveryacentury

ago,

insulincontinues

to

beamongthecostliest

treatments

for

patients

withdiabetes,

withstudiesshowingnearly

onenonadherence.

Furthermore,

theThe

?rst

biosimilar

for

ophthalmologywas

approved

in

the

U.S.burdens

associatedwith

retinal

conditions.However,

?ndingsfromearly

marketresearchwith

U.S.

retina

specialistsindicatea

lackoffamiliarity

andcomfort

withbiosimilars,

whichsuggests

a

criticalneedfor

targeted

educationale?orts

to

helpalleviate

potential

hesitanciesand

closeaccomplishment

for

thebiosimilarthatIt

is

nocoincidence

thatthe

numberone

sellingdrugin

the

world,

Humira,comes

withthe

mostextensivelist

ofbiosimilar

candidates.

With

wideuseinthemanagementofautoimmune

conditionsincludingrheumatoidarthritis,

psoriasisand

Crohn’s

disease,

themarket

entranceofadalimumab

biosimilars

willserve

as

one

ofthe

most

signi?cant

events

toimpact

U.S.healthcare

costsin

recent

history.introductionofan

interchangeableinsulinbiosimilar

may

draw

heightened

attentionto

the

healthcaredeliverysystem

andreimbursement

modelforpharmacybene?tproducts,fuelingadditionalpolicyreform

discussions.was

?rst

approved

in2017.Cyltezo

iscurrently

oneof

seven

FDA

approvedadalimumabbiosimilarsthat

are

lineduptohit

themarketin2023.

Withmultipleothercandidates

in

development,

andvariousproductattributes

associatedwith

eachone,

competition

isexpected

to

be

?erce.(Visit

here

fora

moredetailedHumirabiosimilar

landscapeoverview).AlthoughCyltezo

isthe?rstadalimumabbiosimilarto

achieve

interchangeability

status,

it

isnotexpected

to

bethelast.

Alvotech/Teva,P?zer,

Amgen

and

Organon/SamsungBioepishave

all

revealed

that

they

arepursuing

interchangeability

designationfor

theiradalimumab

candidatesas

well.In

September,

the

FDA

approved

Biogen’sByooviz(ranibizumab-nuna),the

?rstophthalmologybiosimilar

for

Lucentis(ranibizumab)

to

treat

retinal

conditionsincludingneovascular

(wet)age-relatedmacular

degeneration

(AMD).

Thisnoteworthy

approvalis

anticipated

toexpand

treatmentoptionswith

lower-cost,high-quality

therapies

for

theapproximately

11

millionAmericansinfour

patients

ration

insulin.6Betweenknowledge

gaps

earlyon.9Additionally,

the

entrance

of2001and2018,theaverage

listpriceofinsulinproducts

hasincreased

aroundinterchangeablebiosimilars

intothe

retailpharmacy

class

of

trade

will

empower

retailpharmacists,someof

the

most

trusted

andaccessible

healthcare

providers,

to

playakey

role

inin?uencing

biosimilaradoption(withtheability

to

automatically

substituteinterchangeable

products,per

state

laws)and

tochampionthe

education

process

intheircommunities.The

?rst

Humira

(adalimumab)biosimilar

achieved

interchangeabilitydesignation,

representing

the

secondinterchangeable

biosimilar

approvedin

the

U.S.11%annually.7Increasingcompetition

through

theintroduction

ofbiosimilarscreatesopportunity

to

decrease

the?nancialburden

associated

with

theseproducts,whichinturn

could

reduce

therisk

fornegative

outcomesdue

to

medicationdiagnosed

with

AMD.

As

Byooviz

prepares8to

launchthis

year,

retina

specialistsand

ophthalmologists

willhave

moretreatmentoptionsthan

ever

before

totry

totackle

the

economic

andtreatmentIn

October

2021,

Boehringer

Ingelheim’sCyltezo(adalimumab-adbm)

was

grantedinterchangeability

status,a

long-awaited12132021

BIOSIMILARS

LANDSCAPE2021

BIOSIMILARS

LANDSCAPEFigure

3.Use

of

biosimilars

has

grown

signi?cantly

since

2015.908070605089746460524030201003832Regulatory

activities

drew

heightenedattention

to

biosimilars"Savings

frombiosimilarsincreased

toapproximately$8

billion

in

2020alone,

more

thantripling

savingsderived

fromAs

theU.S.

continued

to

strugglewithchallengesrelated

to

theCOVID-19pandemic,

congressional

andgovernmentdiscussionsaround

drugpricing

andlimitthecircumstances

inwhichadditionalmarketexclusivity

isgranted

toa

referenceproduct,ensuring

any

modi?cationrepresents

trueinnovation.

The

goalistoclosepotential

loopholesthat

candelaycompetitionandaccessibilityto

lower-cost

treatment

alternatives,

includingbiosimilars.3a?ordable

care

remained

a

top

priority

in2021.In

April,

President

Bidensigned

intolaw

two

bipartisan

billsaimedat

reducingprescriptiondrugpricesandaddressingsomekeybarriers

to

biosimilaradoption:The

Advancing

Education

onBiosimilarsAct

and

The

EnsuringInnovation

Act.10

Theformer

isintended

to

lower

healthcare

costsby

strengthening

provider

andpatientcon?dence

in

biosimilars

through

enhancededucationale?orts,thereby

increasingutilization,enablinggreater

competitioninthemarket

andlowering

costs

to

theoverallhealthcare

system.

The

latter

isintended

toJan-16Jul-16Jan-17Jul-17Jan-18Jul-18Jan-19Jul-19Jan-20Jul-20Jan-21Jul-21Jan-22RituxanAvastin(bevacizumab)Epogen/Procrit(epoetinalfa)Neulasta(peg?lgrastim)**(rituximab)Additionally,

in

response

to

PresidentBiden’s

Executive

Order,

theDepartment

ofHealthandHumanServices

(HHS)

releaseda

comprehensive

plan

for

addressinghigh

drug

pricesthis

past

September.The

29report,

whichoutlineskeyprinciples

for

drugpricing

reform

throughcompetition,

innovation

and

transparency,mentions“biosimilars”over

90

times

and“interchangeability”25

times.11Herceptin(trastuzumab)Neupogen(?lgrastim)*Remicade(in?iximab)Lantus(insulinglargine)***Source:IQVIA:AccessedviaIQVIANationalSalesPerspective(NSP)SMARTData.(October2021).*FilgrastimexcludesGranix.****NeulastaSyr.onlybiosimilarsmarketshareis75%***InsulinglargineexcludesBasaglar.previous

years."14152021

BIOSIMILARS

LANDSCAPE2021

BIOSIMILARS

LANDSCAPEFigure

4.Adoption

of

biosimilars

typically

accelerates

quicklyafter

market

introduction.9080706050403020100"Although

therehas

been

strongeruse

of

biosimilarsin

oncology,While

thesenoteworthy

events

signalthat

thetideisstarting

toturn

towardgreater

biosimilaradoption,thispastyearalso

proved

that

signi?cantbarriersand

challengesstillexist.

Although

therehasbeenstronger

useofbiosimilarsinoncology(17of

the21biosimilarsonthemarket

have

oncology

indications),progress

in

other

areassuch

asbarriers

and

knowledge

gapsremain

inthe

market,with

increased

desire

for

dataandevidence

around

switching

betweenreference

biologicsandbiosimilars,aswellasbetween

biosimilars.

Collaborationamong

all

healthcarestakeholderswillbeneededto

overcome

manyofthesebarriers

and

to

ensurea

viable

biosimilarsmarketin

the

U.S.0510152025303540455055606570Months

since

?rstbiosimilarlaunchedprogress

inRituxan(rituximab)Avastin(bevacizumab)Epogen/Procrit(epoetinalfa)Neulasta(peg?lgrastim)**other

specialtyareas

such

asrheumatology

hascontinued

to

beslow."rheumatology

hascontinued

to

beslow.Onthepayer

front,

thelandscapecontinues

to

be

complex,with

formularydecisionsthat

have

challenged

theuptakeand

management

of

biosimilarsandpolicies

varying

acrossplans.And

as

marketresearch

continues

to

indicate,

clinicalOur

2022BiosimilarsReport

willtakeadeeper

examinationof

manyoftheseissues

and

what

steps

theindustry

willneedto

taketo

ensure

patients

have

accessto

thesehigh-quality,

lower-cost

treatmentoptions.Herceptin(trastuzumab)Neupogen(?lgrastim)*Remicade(in?iximab)Lantus(insulin

glargine)***Source:IQVIA:AccessedviaIQVIANationalSalesPerspective(NSP)SMARTData.(October2021).*FilgrastimexcludesGranix.**NeulastaSyr.onlybiosimilarsmarketshareis75%.***InsulinglargineexcludesBasaglar.1617PROVIDER

TRENDSThe

majority

of

participating

physicians

are

familiar

withbiosimilars,

but

prescribing

patterns

vary

by

specialty.Oncology(Prescribers)N=323Rh