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Amgen

Biosimilar developer, United States. 8 development products across 8 molecules: adalimumab, aflibercept, bevacizumab, eculizumab, infliximab, rituximab, trastuzumab, ustekinumab.

First approval in the Atlas: Sep 2016, Amjevita, adalimumab (FDA)
FDAproducts approved8
EMAproducts approved6
MHRAproducts approved4
PMDAproducts approved2
HCproducts approved6
CDSCOproducts approved0
EDEproducts registered4
Connections
8molecules8products6 of 7markets0candidates in trials8companies on the same molecules

About Amgen

Amgen is both an originator whose products have been copied, Neupogen, Neulasta, Enbrel and Prolia among them, and one of the largest biosimilar makers. It was first to file and first to launch adalimumab and ustekinumab biosimilars in the United States, first with bevacizumab and trastuzumab there too, and first to launch aflibercept after winning a patent case. Eight molecules are approved in the United States, six in Europe, six in Canada, four registered in the UAE and two in Japan through Daiichi Sankyo.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
AdalimumabAmjevita / Amgevita ABP 501Sep 2016Mar 2017MHRA·Nov 2020·EDE5/7
AfliberceptPavblu ABP 938Aug 2024Apr 2025MHRA·Jul 2025··4/7
BevacizumabMvasi ABP 215Sep 2017Jan 2018·Sep 2019Apr 2018·Apr 20205/7
EculizumabBkemv / Bekemv ABP 959May 2024Apr 2023MHRA·withdrawn··3/7
InfliximabAvsola ABP 710Dec 2019···Mar 2020··2/7
RituximabRiabni ABP 798Dec 2020···withdrawn··1/7
TrastuzumabKanjinti ABP 980Jun 2019May 2018·Sep 2018Feb 2020·Feb 20195/7
UstekinumabWezlana / Wezenla ABP 654Oct 2023Jun 2024MHRA·Nov 2024·Oct 20245/7

Month shown is the first approval or registration of that product in that market.

In development

ClinicalTrials.gov lists two comparative trials sponsored by Amgen for two molecules: adalimumab, ustekinumab. All of these candidates already have at least one approval in the seven markets.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
AdalimumabABP 501AmgenHumiraPhase 3SwitchingCompletedOct 2021Dec 2022Amjevita / AmgevitaNCT05073315
UstekinumabABP 654AmgenStelaraPhase 3SwitchingCompletedMar 2021Feb 2023Wezlana / WezenlaNCT04761627

Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.

Companies on the same molecules

Developers whose portfolios overlap most with Amgen, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.

CelltrionSeven shared molecules: adalimumab, aflibercept, bevacizumab, infliximab, rituximab, trastuzumab, ustekinumab10 molecules in its portfolioSamsung BioepisSeven shared molecules: adalimumab, aflibercept, bevacizumab, eculizumab, infliximab, trastuzumab, ustekinumab10 molecules in its portfolioReliance Life SciencesSix shared molecules: adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, ustekinumab14 molecules in its portfolioPfizerFive shared molecules: adalimumab, bevacizumab, infliximab, rituximab, trastuzumab7 molecules in its portfolioZydus LifesciencesFive shared molecules: adalimumab, aflibercept, bevacizumab, rituximab, trastuzumab11 molecules in its portfolioBiocon BiologicsFour shared molecules: aflibercept, bevacizumab, trastuzumab, ustekinumab9 molecules in its portfolioAlvotechThree shared molecules: adalimumab, aflibercept, ustekinumab5 molecules in its portfolioBiocadThree shared molecules: infliximab, rituximab, trastuzumab3 molecules in its portfolio

Chronology

Compare Amgen with other developers on the comparison page.

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Data current to September 2026.