• FDA and EMA both approve biosimilar versions of Stelara® (ustekinumab), Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab).
  • FDA approves 19 biosimilars in 2024.

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare.  These products are highly similar to an already-approved reference product, offering a more affordable treatment option without compromising on safety or efficacy.  As biosimilars gain traction worldwide, regulatory bodies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) play a critical role in shaping their market introduction.  While both agencies share similar goals of ensuring patient safety and promoting access to high-quality therapeutics, their regulatory pathways and approval trends show notable differences.

One such difference is that the EMA has historically been quicker than the FDA in approving biosimilars.  Since 2005, the biosimilar regulatory framework in Europe has been implemented through the Committee for Medicinal Products for Human Use (CHMP) under the EMA.  The CHMP provides initial assessments for marketing authorization of new medicines that are ultimately approved centrally by the EMA.  Since Sandoz’s somatotropin biosimilar, Omnitrope®, was first authorized on April 12, 2006, an additional 112 applications have been approved in Europe.  Sixteen of the authorizations have been withdrawn post-approval (Table 1).  On average, the EMA takes about 1-2 years from submission of a biosimilar application to approval.

In contrast, the FDA’s biosimilar approval process has been relatively slow, with initial approval times averaging 3-4 years for the first generation of biosimilars.  This delay in approval is partly due to the FDA’s more rigorous evaluation of biosimilars and the additional data required to achieve interchangeability designation.  Additionally, the U.S. did not implement a regulatory framework for biosimilar evaluation until after enactment of the Biologics Price Competition and Innovation Act (BPCIA) of 2009.  As the EMA had already approved over a dozen biosimilars by this time, Europe had a significant head start on both the number of approved biosimilars and the regulatory process for approving more.  Sandoz’s filgrastim biosimilar, Zarxio®, received the first U.S. approval in 2015, whereas nine filgrastim biosimilars have been approved in Europe dating back to multiple authorizations in 2008.  Despite the FDA’s relatively slower biosimilar approval pace, the U.S. biosimilar market has managed to grow continuously over the past decade.  Subsequent to Zarxio®’s approval, 63 other biosimilar drugs have gained U.S. approval to date including 14 interchangeable products (Table 2).

As illustrated in the following graph, while the EU’s significant head start and higher approval rate led to an imbalance in the number of biosimilar drugs available in the respective markets, the FDA has increased the rate of approval in recent years.  In 2024 alone, the FDA approved 19 biosimilars, the most approvals in a single year by either regulatory body to date.

Despite the high number of approvals in 2024, launches of several FDA-approved biosimilars, such as aflibercept and ustekinumab, are delayed due to patent litigations or settlements between parties.  Additionally, there are often  regulatory hurdles and costs faced by biosimilar applicants that deter or delay biosimilar products from reaching the U.S. market.

Looking forward, there are currently 38 biosimilar applications under review by the EMA for marketing authorization (Table 3).  As an increasing number of patents expire on blockbuster biologic drugs, the number of abbreviated biologics license applications is also increasing.  Biosimilars for more than 31 different original biologics are currently navigating biosimilar pathways or are in late stage development in the U.S. (Table 4).  

Table 1. European Medicines Agency List of Approved Biosimilar Drugs.

Biosimilar Proprietary NameDrug ProductOwnerStatus*Authorization/ Withdrawal Date
Abasaglar
(previously Abasria)
Insulin GlargineEli Lilly Regional
Operations GmbH
Authorized9/9/2014
AbevmyBevacizumabMylan IRE Healthcare LimitedAuthorized4/21/2021
AbseamedEpoetin AlfaMedice Arzneimittel Pütter GmbH & Co. KgAuthorized8/28/2007
AccofilFilgrastimAccord Healthcare LtdAuthorized9/18/2014
AdmelogInsulin lisproSanofiAuthorized5/19/2017
AlpheonRecombinant Human
Interferon Alfa-2a
Biopartners GmbHRefused
AlymsysBevacizumabMabxience Research SLAuthorized3/26/2021
AmgevitaAdalimumabAmgen EuropeAuthorized3/22/2017
AmsparityAdalimumabPfizer Europe MA EEIGAuthorized2/13/2020
AvziviBevacizumabFGK Representative Service GmbHAuthorized7/26/2024
AybintioBevacizumabSamsung Bioepis NL B.V.Authorized8/20/2020
BekemvEculizumabAmgen Technology UCAuthorized4/19/2023
BemfolaFollitropin AlfaGedeon Richter Plc.Authorized3/27/2014
BenepaliEtanerceptSamsung Bioepis
Uk Limited (Sbuk)
Authorized1/14/2016
BinocritEpoetin AlfaSandoz GmbHAuthorized8/28/2007
BiograstimFilgrastimAbz-Pharma GmbHWithdrawn9/15/2008
BlitzimaRituximabCelltrionAuthorized7/13/2017
ByoovizRanibizumabSamsung BioepisAuthorized8/18/2021
CyltezoAdalimumabBoehringer Ingelheim International GmbHAuthorized Withdrawn11/10/2017 1/15/2019
DyrupegPegfilgrastimCuraTeQ BoilogiceWithdrawn6/08/2023
EksunbiUstekinumabSamsung Bioepis NL B.V.Authorized9/12/2024
Epoetin Alfa HexalEpoetin AlfaHexal AgAuthorized8/28/2007
EpysqliEculizumabSamsung Bioepis NL B.V.Authorized5/26/2023
EquidacentBevacizumabCentus Biotherapeutics Europe LimitedAuthorized Withdrawn9/25/2020 10/11/2021
ErelziEtanerceptSandoz GmbHAuthorized6/23/2017
Filgrastim HexalFilgrastimHexal AgAuthorized6/2/2009
Filgrastim ratiopharmFilgrastimRatiopharm GmbHWithdrawn9/15/2008
FlixabiInfliximabSamsung Bioepis
Uk Limited (SBUK)
Authorized5/26/2016
FulphilaPegfilgrastimMylan S.A.S.Authorized11/20/2018
FymskinaUstekinumabFormycon AGAuthorized9/25/2024
GrastofilFilgrastimApotex Europe BvAuthorized10/18/2013
GrasustekPegfilgrastimJuta Pharma GmbHAuthorized4/26/2019
HalimatozAdalimumabSandoz GmbHAuthorized Withdrawn7/26/2018 12/18/2020
HefiyaAdalimumabSandoz GmbHAuthorized7/26/2018
HerwendaTrastuzumabSandoz GmbHAuthorized11/15/2023
HerzumaTrastuzumabCelltrion Healthcare Hungary Kft.Authorized2/9/2018
HukyndraAdalimumabStada Arzneimittel AGAuthorized11/15/2021
HulioAdalimumabMylan S.A.S.Authorized9/19/2018
HyrimozAdalimumabSandoz GmbHAuthorized7/26/2018
IdacioAdalimumabFresenius Kabi Deutschland GmbHAuthorized4/2/2019
ImraldiAdalimumabSamsung Bioepis UK Limited (SBUK)Authorized8/24/2017
ImuldosaUstekinumabAccord Healthcare S.L.U.Authorized12/12/2024
InflectraInfliximabHospira Uk LimitedAuthorized9/10/2013
InhixaEnoxaparin SodiumTechdow Europe AbAuthorized9/15/2016
InpremziaInsulin humanBaxter Holding B.V.Authorized Withdrawn4/25/2022 4/20/2023
Insulin aspart SanofiInsulin aspartateSanofi-Aventis groupeAuthorized7/26/2020
JubbontiDenosumabSandoz GmbHAuthorized5/16/2024
KanjintiTrastuzumabAmgen/AllerganAuthorized5/16/2018
KaulivTeriparatodeStrides Pharma LimitedAuthorized1/12/2023
Kirsty (previously Kixelle)Insulin aspartMylanAuthorized2/8/2021
KromeyaAdalimumabFresenius Kabi Deutschland GmbHAuthorized Withdrawn4/2/2019 12/17/2019
LextemyBevacizumabMylan IRE Healthcare LimitedAuthorized Withdrawn4/21/2021 6/21/2021
LibmyrisAdalimumabStada Arzneimittel AGAuthorized11/12/2021
LivogivaTeriparatideTheramex Ireland LimitedAuthorized8/27/2020
LusdunaInsulin GlargineMerck Sharp &
Dohme Limited
Authorized Withdrawn4/1/2017 10/29/2018
LyumjevInsulin lisproEli Lilly Nederland B.V.Authorized3/24/2020
MovymiaTeriparatideStada Arzneimittel AgAuthorized1/11/2017
MvasiBevacizumabAmgen Europe B.V.Authorized1/15/2018
NepextoEtanerceptMylan and LupinAuthorized6/4/2020
NivestimFilgrastimHospira Uk LtdAuthorized6/8/2010
NyvepriaPegfilgrastimPfizer Europe MA EEIGAuthorized11/19/2020
OgivriTrastuzumabViatrisAuthorized12/12/2018
OmlycloOmalizumabCelltrion Healthcare Hungary Kft,Authorized5/16/2024
OmnitropeSomatropinSandoz GmbHAuthorized4/12/2006
OnbevziBevacizumabSamsung Bioepis Co., Ltd.Authorized Withdrawn1/13/2021 10/24/2024
OntruzantTrastuzumabSamsung Bioepis Co., Ltd.Authorized11/17/2017
OpuvizAfliberceptSamsung Bioepis NL B.V.Authorized9/19/2024
OtulfiUstekinumabFresenius Kabi Deutschland GmbHAuthorized9/25/2024
OvaleapFollitropin AlfaTeva Pharma B.V.Authorized9/27/2013
OyavasBevacizumabSTADA Arzneimittel AGAuthorized3/26/2021
Pegfilgrastim Mundipharma (Cegfila)PegfilgrastimMundipharma Biologics S.L.Authorized12/19/2019
PelgrazPegfilgrastimAccord Healthcare LimitedAuthorized9/25/2018
PelmegPegfilgrastimCinfa Biotech S.L.Authorized11/20/2018
PyzchivaUstekinumabSamsung Bioepis NL B.V.Authorized4/19/2024
QutavinaTeriparatideEuroGenerics Holdings BVAuthorized Withdrawn8/31/2020 11/26/2020
Ranibizumab MidasRanibizumabMidas Pharma GmbHAuthorized9/19/2024
RanivisioRanibizumabMidas Pharma GmbHAuthorized8/25/2022
RatiograstimFilgrastimRatiopharm GmbHAuthorized9/15/2008
RemsimaInfliximabCelltrion Healthcare
Hungary Kft.
Authorized9/10/2013
RetacritEpoetin ZetaHospira Uk LimitedAuthorized12/18/2007
RimmyrahRanibizumabQilu Pharma Spain S.L.Authorized1/05/2024
RitemviaRituximabCelltrionAuthorized Withdrawn7/13/2017 6/21/2021
Rituzena (previously Tuxella)RituximabCelltrionAuthorized Withdrawn7/13/2017 4/12/2019
RixathonRituximabSandoz GmbHAuthorized6/15/2017
RiximyoRituximabSandoz GmbHAuthorized6/15/2017
RuxienceRituximabPfizer Europe MA EEIGAuthorized4/1/2020
SemgleeInsulin glargineMylan S.A.S.Authorized3/27/2018
SilapoEpoetin ZetaStada Arzneimittel AgAuthorized12/18/2007
SolumarvInsulin HumanMarvel Lifesciences LtdRefused
SolymbicAdalimumabAmgen EuropeAuthorized Withdrawn3/22/2017 6/15/2018
SondelbayTeriparatideAccord Healthcare S.L.U.Authorized3/24/2022
StimufendPegfilgrastimFresenius Kabi Deutschland GmbHAuthorized3/28/2022
TerrosaTeriparatideGedeon Richter Plc.Authorized1/4/2017
TevagrastimFilgrastimTeva GmbHAuthorized9/15/2008
ThorinaneEnoxaparin SodiumPharmathen S.A.Authorized9/15/2016
TrazimeraTrastuzumabPfizerAuthorized7/26/2018
Truvelog Mix 30Insulin aspartSanofi Winthrop IndustrieAuthorized4/25/2022
TruximaRituximabCelltrion Healthcare
Hungary Kft.
Authorized2/17/2017
TuznueTrastuzumabPrestige Biopharma BelgiumAuthorized9/19/2024
TyenneTocilizumabFresenius Kabi Deutschland GmbHAuthorized9/15/2023
TyrukoNatalizumabSandoz GmbHAuthorized9/22/2023
UdenycaPegfilgrastimCoherus/ERA Consulting GmbHAuthorized Withdrawn9/25/2018 2/4/2021
UzpruvoUstekinumabStada ArzneimittelAuthorized1/05/2024
VegzelmaBevacizumabCelltrion HealthcareAuthorized8/17/2022
WezenlaUstekinumabAmgen Technology UCAuthorized6/20/2024
WyostDenosumabSandoz GmbHAuthorized5/17/2024
XimluciRanibizumabSTADA Arzneimittel AGAuthorized3/26/2022
YesafiliAfliberceptBiosimilar Collaborations Ireland LimitedAuthorized7/20/2023
YuflymaAdalimumabCelltrion Healthcare
Hungary Kft.
Authorized2/11/2021
ValtropinSomatropinBiopartners GmbHWithdrawn4/24/2006
ZarzioFilgrastimSandoz GmbHAuthorized2/6/2009
ZercepacTrastuzumabAccord Healthcare S.L.U.Authorized7/28/2020
ZesslyInfliximabSandoz GmbHAuthorized5/18/2018
ZiextenzoPegfilgrastimSandoz GmbHAuthorized11/22/2018
ZirabevBevacizumabPfizerAuthorized2/14/2019

Table 2. U.S. Food and Drug Administration List of Approved Biosimilar Drugs.

No.Drug ProductCompanyReference Product and SponsorMarketing StatusFDA Approval Date
64Steqeyma (Ustekinumab-stba)CelltrionJanssen Stelara®Not Available Launch Expected February 202512/17/2024
63Yesintek (ustekinumab-kfce)Biocon Biologics Inc.Janssen Stelara®Not Available Launch Expected February 202511/29/2024
62Imuldosa (ustekinumab-srlf)Accord BiopharmaJanssen Stelara®Not Available Launch Expected May 202510/10/2024
61Otulfi (ustekinumab-aauz)Fresenius KabiJanssen Stelara®Not Available Launch Expected February 20259/27/2024
60Pavblu (aflibercept-ayyh)AmgenRegeneron Eylea®Not Available8/23/2024
59Enzeevu (aflibercept-abzv)SandozRegeneron Eylea®Not Available8/09/2024
58Epysqli (eculizumab-aagh)Samsung BioepisAlexion Soliris®Not Available7/19/2024
57Ahzantive (aflibercept-mrbb)Formycon AGRegeneron Eylea®Not Available6/28/2024
56Nypozi (filgrastim-txid)Tanvex BiopharmaAmgen Neupogen®Not Available6/28/2024
55Pyzchiva (ustekinumab-ttwe)Samsung BioepisJanssen Stelara®Not Available Launch Expected February 20256/28/2024
54Bkemv (eculizumab-aeeb)AmgenAlexion Soliris®Not Available Launch Expected March 20255/28/2024
53Yesafili (aflibercept-jbvf)Biocon BiologicsRegeneron Eylea®Not Available Launch Delayed to 20255/20/2024
52Opuviz (aflibercept-yszy)Samsung BioepisRegeneron Eylea®Not Available Launch Delayed to 20255/20/2024
51Hercessi (trastuzumab-strf)Accord BiopharmaGenentech Herceptin®Launched November 20244/25/2024
50Selarsdi (ustekinumab-aekn)AlvotechJanssen Stelara®Not Available Launch Expected February 20254/16/2024
49Tyenne (tocilizumab-aazg)Fresenius KabiGenentech Actemra®Launched April 20243/05/2024
48Jubbonti (denosumab-bbdz)SandozAmgen Prolia®Not Available Launch Expected May 20253/05/2024
47Wyost (denosumab-bbdz)SandozAmgen Xgeva®Not Available Launch Expected May 20253/05/2024
46Simlandi (adalimumab-ryvk)AlvotechAbbVie Humira®Launched May 20242/23/2024
45Avzivi (bevacizumab-tnjn)Bio-thera SolutionsGenentech Avastin®Not Available12/06/2023
44Wezlana (ustekinumab-auub)AmgenJanssen Stelara®Not Available Launch Delayed to 202510/31/2023
43Tofidence (tocilizumab-bavi)BiogenGenentech Actemra®Launched May 20249/29/2023
42Tyruko (natalizumab-sztn)SandozBiogen Tysabri®Launched February 20248/24/2023
41Yuflyma (adalimumab-aaty)CelltrionAbbVie Humira®Launched July 20235/23/2023
40Idacio (adalimumab-aacf)Fresenius KabiAbbVie Humira®Launched July 202312/13/2022
39Vegzelma (bevacizumab-adcd)CelltrionGenentech Avastin®Launched April 20239/27/2022
38Stimufend (pegfilgrastim-fpgk)Fresenius KabiAmgen Neulasta®Launched February 20239/01/2022
37Cimerli (ranibizumab-eqrn)SandozGenentech Lucentis®Launched October 20228/02/2022
36Fylnetra (pegfilgrastim-pbbk)Kashiv BiosciencesAmgen Neulasta®Launched May 20235/26/2022
35Alymsys (bevacizumab-maly)AmnealGenentech Avastin®Launched October 20224/13/2022
34Releuko (filgrastim-ayow)Kashiv Biosciences & Amneal PharmaceuticalsAmgen Neupogen®Launched November 20222/28/2022
33YusimryTM (adalimumab-aqvh)CoherusAbbVie Humira®Launched July 2023  12/20/2021
32RezvoglarTM (insulin glargine-aglr)Eli LillySanofi Lantus®Launched April 2023  12/20/2021
31ByoovizTM (ranibizumab-nuna)Samsung Bioepis and BiogenGenentech Lucentis®Launched July 20229/17/2021
30SemgleeTM (insulin glargine-yfqn) INTERCHANGEABLEViatris and Biocon BiologicsSanofi Lantus®Launched November 20217/28/2021
29RiabniTM (rituximab-arrx)AmgenBiogen and Genentech Rituxan®Launched January 202112/17/2020
28HulioTM (adalimumab-fkjp)MylanAbbVie Humira®Launched July 20237/6/2020
27NyvepriaTM (pegfilgrastim-apgf)PfizerAmgen Neulasta®Launched January 20216/10/2020
26AvsolaTM (infliximab-axxq)AmgenJanssen Remicade®Launched July 202012/6/2019
25AbriladaTM (adalimumab-afzb)PfizerAbbVie Humira®Launched November 202311/15/2019
24ZiextenzoTM (pegfilgrastim-bmez)SandozAmgen Neulasta®Launched November 201911/4/2019
23HadlimaTM (adalimumab-bwwd)Samsung BioepisAbbVie Humira®Launched July 20237/23/2019
22RuxienceTM (rituximab-pvvr)PfizerBiogen and Genentech Rituxan®Launched January 20207/23/2019
21ZirabevTM (bevacizumab-bvzr)PfizerGenentech/Roche Avastin®Launched December 20196/28/2019
20KanjintiTM (trastuzumab-anns)AmgenRoche/Genentech Herceptin®Launched July 20196/13/2019
19EticovoTM (etanercept-ykro)Samsung BioepisAmgen Enbrel®

Not available4/25/2019
18TrazimeraTM (trastuzumab-qyyp)PfizerRoche/Genentech Herceptin®Launched February 20203/11/2019
17Ontruzant™ (trastuzumab-dttb)Samsung BioepisRoche/Genentech Herceptin®Launched April 20201/18/2019
16Herzuma™ (trastuzumab-pkrb)Celltrion and TevaRoche/Genentech Herceptin®Launched March 202012/14/2018
15Truxima™ (rituximab-abbs)Celltrion and TevaBiogen and Genentech Rituxan®Launched November 201911/28/2018
14Udenyca™ (pegfilgrastim-cbqv)Coherus BioSciencesAmgen Neulasta®Launched January 201911/2/2018
13Hyrimoz™ (adalimumab-adaz)SandozAbbVie Humira®Launched July 202310/30/2018
12NivestymTM (filgrastim-aafi)PfizerAmgen Neupogen®Launched October 20187/20/2018
11FulphilaTM (pegfilgrastim-jmdb)Mylan/BioconAmgen Neulasta®Launched July 20186/4/2018
10Retacrit® (epoetin alfa-epbx)PfizerJanssen Procrit®Launched November 20185/15/2018
9Ixifi® (infliximab-qbtx)PfizerJanssen Remicade®Not Available12/13/2017
8Ogivri® (trastuzumab-dkst)Mylan/BioconRoche/Genentech Herceptin®Launched December 201912/01/2017
7MvasiTM (bevacizumab-awwb)Amgen AllerganGenentech/Roche Avastin®Launched July 20199/14/2017
6CyltezoTM (adalimumab-adbm) INTERCHANGEABLEBoehringer Ingelheim International GmbHAbbVie Humira®Launched July 20238/25/2017
5Renflexis® (infliximab-abda)Samsung BioepisJanssen Remicade®Launched July 20174/21/2017
4Amjevita® (adalimumab-atto)AmgenAbbVie Humira®Launched January 20239/23/2016
3Erelzi ® (etanercept-szzs)SandozAmgen Enbrel®
(etanercept)
Not Available8/30/2016
2Inflectra® (infliximab-dyyb)Celltrion/PfizerJanssen Remicade®Launched November 20164/05/2016
1Zarxio® (filgrastim-sndz)SandozAmgen Neupogen®Launched
September 2015
03/06/2015

Table 3. European Medicines Agency List of Biosimilars Under Evaluation for Marketing Approval (Source: EMA list of applications for new human medicines compiled on December 2, 2024 and published on December 9, 2024).

Drug ProductReference Product Proprietary NameReference Product SponsorNumber of Applications
AfliberceptEylea®Regeneron6
DenosumabProlia®Amgen20
FilgrastimNeupogen®Amgen1
GolimumabSimponi®Janssen1
Insulin aspart  1
Insulin glargine  1
Insulin human  1
Insulin lispro  1
PegfilgrastimNeulasta®Amgen2
RilonaceptArcalyst®Regeneron1
TeriparatideForteo®/Forsteo®Eli Lilly1
TocilizumabActemra®Genentech1
TrastuzumabHerceptin®Roche/Genentech1

Table 4. Biologics having already expired or nearing primary patent expiry in the U.S. and biologics that have biosimilars in the regulatory pipeline. 

Drug ProductPrimary U.S. Patent Expiry*
OnabotulinumtoxinA (Botox®)Primary patents long-expired, various use patents pending
Insulin products (various)Primary patents long-expired
Filgrastim (Neupogen®)2013
Epoetin alfa (Epogen®)2013
Pegfilgrastim (Neulasta®)2015
Adalimumab (Humira®)2016
Rituximab (Rituxan®)2018
Cetuximab (Erbitux®)2018
Omalizumab (Xolair®)2018
Infliximab (Remicade®)2018
Teriparatide (Forteo®)2019
Bevacizumab  (Avastin®)2019
Trastuzumab (Herceptin®)2019
Tocilizumab (Acetmra®)2019
Abatacept (Orencia®)2019
Ranibizumab (Lucentis®)2020
Panitumumab (Vectibix®)2020
Eculizumab (Soliris®)2021
Aflibercept (Eylea®)2023
Denosumab (Prolia® and Xgeva®)2023
Palivizumab (Synagis®)2023
Ustekinumab (Stelara®)2023
Certolizumab pegol (Cimzia®)2024
Golimumab (Simponi®)2024
Darbepoetin alfa (Aranesp®)2024
Pertuzumab (Perjeta®)2024
Canakinumab (Ilaris®)2024
Benralizumab (Fasenra®)2024
Ipilimumab (Yervoy®)2025
Natalizumab (Tysabri®)2027
Etanercept (Enbrel®)2028
Pembrolizumab (Keytruda®)2028
Ocrelizumab (Ocrevus®)2028
Nivolumab (Opdivo®)2028
Tezepelumab (Tezspire®)2028
Anifrolumab (Saphnelo®)2029
Vedolizumab (Entyvio®)2031
Tremelimumab (Imjudo®)2031
Nirsevimab (Beyfortus®)2035
Ravulizumab (Ultomiris®)2035

*Expiration dates are estimated and subject to change, for example, if pending patent term extension applications are granted.

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