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Samsung Bioepis

Biosimilar developer, South Korea. 10 development products across 10 molecules: adalimumab, aflibercept, bevacizumab, denosumab, eculizumab, etanercept, infliximab, ranibizumab, trastuzumab, ustekinumab.

First approval in the Atlas: Jan 2016, Benepali, etanercept (EMA)
FDAproducts approved9
EMAproducts approved10
MHRAproducts approved10
PMDAproducts approved0
HCproducts approved7
CDSCOproducts approved0
EDEproducts registered1
Connections
10molecules10products5 of 7markets0candidates in trials8companies on the same molecules

About Samsung Bioepis

Samsung Bioepis has ten biosimilar molecules approved in Europe and nine in the United States, sold through partners: Biogen in Europe and for eye medicines, Organon in the United States, and Sandoz for ustekinumab. Its etanercept, Benepali, was the first in Europe and took a large share there; its ranibizumab, Byooviz, was the first eye biosimilar in the West; its eculizumab is one of only two in the world. It has not filed in Japan and has no Indian products.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
AdalimumabHadlima / Imraldi SB5Jul 2019Aug 2017MHRA·May 2018··4/7
AfliberceptOpuviz SB15May 2024Nov 2024MHRA····3/7
BevacizumabAybintio SB8·Aug 2020MHRA·Nov 2021··3/7
DenosumabOspomyv / Xbryk / Obodence SB16Feb 2025Feb 2025MHRA····3/7
EculizumabEpysqli SB12Jul 2024May 2023MHRA····3/7
EtanerceptEticovo / Benepali SB4Apr 2019Jan 2016MHRA·Aug 2016··4/7
InfliximabRenflexis / Flixabi SB2Apr 2017May 2016MHRA·Dec 2017·Oct 20215/7
RanibizumabByooviz SB11Sep 2021Aug 2021MHRA·Mar 2022··4/7
TrastuzumabOntruzant SB3Jan 2019Nov 2017MHRA·Jan 2022··4/7
UstekinumabPyzchiva SB17Jun 2024Apr 2024MHRA·Aug 2024··4/7

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

In development

ClinicalTrials.gov lists fifteen comparative trials sponsored by Samsung Bioepis for ten molecules: adalimumab, aflibercept, bevacizumab, denosumab, eculizumab, etanercept, infliximab, ranibizumab, trastuzumab, ustekinumab. All of these candidates already have at least one approval in the seven markets.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
AdalimumabSB5Samsung BioepisHumiraPhase 4Comparative PKCompletedAug 2022Apr 2023Hadlima / ImraldiNCT05510063
AdalimumabSB5Samsung BioepisHumiraPhase 3Comparative efficacyCompletedMay 2014Apr 2015Hadlima / ImraldiNCT02167139
AfliberceptSB15Samsung BioepisEyleaPhase 3Comparative efficacyCompletedJun 2020Apr 2021OpuvizNCT04450329
BevacizumabSB8Samsung BioepisAvastinPhase 1Comparative PKCompletedApr 2015Sep 2015AybintioNCT02453672
BevacizumabSB8Samsung BioepisAvastinPhase 3Comparative efficacyCompletedJul 2016Jan 2018AybintioNCT02754882
DenosumabSB16Samsung BioepisProliaPhase 3Comparative efficacyCompletedNov 2020Jun 2022Ospomyv / Xbryk / ObodenceNCT04664959
DenosumabSB16Samsung BioepisProliaPhase 1Comparative PKCompletedOct 2020Nov 2022Ospomyv / Xbryk / ObodenceNCT04621318
EculizumabSB12Samsung BioepisSolirisPhase 3Comparative efficacyCompletedAug 2019Sep 2021EpysqliNCT04058158
EculizumabSB12Samsung BioepisSolirisPhase 1Comparative PKCompletedNov 2018Mar 2019EpysqliNCT03722329
EtanerceptSB4Samsung BioepisEnbrelPhase 3Comparative efficacyCompletedJun 2013Apr 2014Eticovo / BenepaliNCT01895309
InfliximabSB2Samsung BioepisRemicadePhase 3Comparative efficacyCompletedAug 2013Sep 2014Renflexis / FlixabiNCT01936181
RanibizumabSB11Samsung BioepisLucentisPhase 3Comparative efficacyCompletedMar 2018May 2019ByoovizNCT03150589
TrastuzumabSB3Samsung BioepisHerceptinPhase 3Comparative efficacyCompletedApr 2014Mar 2016OntruzantNCT02149524
UstekinumabSB17Samsung BioepisStelaraPhase 1Comparative PKCompletedFeb 2021Apr 2022PyzchivaNCT04772274
UstekinumabSB17Samsung BioepisStelaraPhase 3Comparative efficacyCompletedJul 2021Feb 2022PyzchivaNCT04967508

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 Samsung Bioepis, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.

Reliance Life SciencesEight shared molecules: adalimumab, bevacizumab, denosumab, etanercept, infliximab, ranibizumab, trastuzumab, ustekinumab14 molecules in its portfolioAmgenSeven shared molecules: adalimumab, aflibercept, bevacizumab, eculizumab, infliximab, trastuzumab, ustekinumab8 molecules in its portfolioCelltrionSeven shared molecules: adalimumab, aflibercept, bevacizumab, denosumab, infliximab, trastuzumab, ustekinumab10 molecules in its portfolioBiocon BiologicsFive shared molecules: aflibercept, bevacizumab, denosumab, trastuzumab, ustekinumab9 molecules in its portfolioIntas PharmaceuticalsFive shared molecules: bevacizumab, denosumab, etanercept, ranibizumab, trastuzumab12 molecules in its portfolioZydus LifesciencesFive shared molecules: adalimumab, aflibercept, bevacizumab, ranibizumab, trastuzumab11 molecules in its portfolioAlvotechFour shared molecules: adalimumab, aflibercept, denosumab, ustekinumab5 molecules in its portfolioEnzene BiosciencesFour shared molecules: adalimumab, bevacizumab, denosumab, ranibizumab6 molecules in its portfolio

Chronology

Compare Samsung Bioepis with other developers on the comparison page.

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Data current to September 2026.