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
PMDAproducts approved0
HCproducts approved7
CDSCOproducts approved0
EDEproducts registered1
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Adalimumab | Hadlima / Imraldi SB5 | Jul 2019 | Aug 2017 | · | May 2018 | · | · |
| Aflibercept | Opuviz SB15 | May 2024 | Nov 2024 | · | · | · | · |
| Bevacizumab | Aybintio SB8 | · | Aug 2020 | · | Nov 2021 | · | · |
| Denosumab | Ospomyv / Xbryk / Obodence SB16 | Feb 2025 | Feb 2025 | · | · | · | · |
| Eculizumab | Epysqli SB12 | Jul 2024 | May 2023 | · | · | · | · |
| Etanercept | Eticovo / Benepali SB4 | Apr 2019 | Jan 2016 | · | Aug 2016 | · | · |
| Infliximab | Renflexis / Flixabi SB2 | Apr 2017 | May 2016 | · | Dec 2017 | · | Oct 2021 |
| Ranibizumab | Byooviz SB11 | Sep 2021 | Aug 2021 | · | Mar 2022 | · | · |
| Trastuzumab | Ontruzant SB3 | Jan 2019 | Nov 2017 | · | Jan 2022 | · | · |
| Ustekinumab | Pyzchiva SB17 | Jun 2024 | Apr 2024 | · | Aug 2024 | · | · |
Month shown is the first approval or registration of that product in that market.
Chronology
- EMAJan 2016Benepali, etanercept
- EMAMay 2016Flixabi, infliximab
- HCAug 2016Brenzys, etanercept
- FDAApr 2017Renflexis, infliximab
- EMAAug 2017Imraldi, adalimumab
- EMANov 2017Ontruzant, trastuzumab
- HCDec 2017Renflexis, infliximab
- HCMay 2018Hadlima, adalimumab
- FDAJan 2019Ontruzant, trastuzumab
- FDAApr 2019Eticovo, etanercept
- FDAJul 2019Hadlima, adalimumab
- EMAAug 2020Aybintio, bevacizumab
- EMAAug 2021Byooviz, ranibizumab
- FDASep 2021Byooviz, ranibizumab
- EDEOct 2021Renflexis, infliximab
- HCNov 2021Aybintio, bevacizumab
- HCJan 2022Ontruzant, trastuzumab
- HCMar 2022Melvizo, ranibizumab
- EMAMay 2023Epysqli, eculizumab
- EMAApr 2024Pyzchiva, ustekinumab
- FDAMay 2024Opuviz, aflibercept
- FDAJun 2024Pyzchiva, ustekinumab
- FDAJul 2024Epysqli, eculizumab
- HCAug 2024Pyzchiva, ustekinumab
- EMANov 2024Opuviz, aflibercept
- EMAFeb 2025Obodence, denosumab
- EMAFeb 2025Xbryk, denosumab
- FDAFeb 2025Ospomyv, denosumab
- FDAFeb 2025Xbryk, denosumab
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