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
PMDAproducts approved2
HCproducts approved6
CDSCOproducts approved0
EDEproducts registered4
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Adalimumab | Amjevita / Amgevita ABP 501 | Sep 2016 | Mar 2017 | · | Nov 2020 | · | EDE |
| Aflibercept | Pavblu ABP 938 | Aug 2024 | Apr 2025 | · | Jul 2025 | · | · |
| Bevacizumab | Mvasi ABP 215 | Sep 2017 | Jan 2018 | Sep 2019 | Apr 2018 | · | Apr 2020 |
| Eculizumab | Bkemv / Bekemv ABP 959 | May 2024 | Apr 2023 | · | withdrawn | · | · |
| Infliximab | Avsola ABP 710 | Dec 2019 | · | · | Mar 2020 | · | · |
| Rituximab | Riabni ABP 798 | Dec 2020 | · | · | withdrawn | · | · |
| Trastuzumab | Kanjinti ABP 980 | Jun 2019 | May 2018 | Sep 2018 | Feb 2020 | · | Feb 2019 |
| Ustekinumab | Wezlana / Wezenla ABP 654 | Oct 2023 | Jun 2024 | · | Nov 2024 | · | Oct 2024 |
Month shown is the first approval or registration of that product in that market.
Chronology
- FDASep 2016Amjevita, adalimumab
- EMAMar 2017Amgevita, adalimumab
- FDASep 2017Mvasi, bevacizumab
- EMAJan 2018Mvasi, bevacizumab
- HCApr 2018Mvasi, bevacizumab
- EMAMay 2018Kanjinti, trastuzumab
- PMDASep 2018Trastuzumab BS Daiichi Sankyo, trastuzumab
- EDEFeb 2019Kanjinti, trastuzumab
- FDAJun 2019Kanjinti, trastuzumab
- PMDASep 2019Bevacizumab BS Amgen, bevacizumab
- FDADec 2019Avsola, infliximab
- HCFeb 2020Kanjinti, trastuzumab
- HCMar 2020Avsola, infliximab
- EDEApr 2020Mvasi, bevacizumab
- HCNov 2020Amgevita, adalimumab
- FDADec 2020Riabni, rituximab
- EMAApr 2023Bekemv, eculizumab
- FDAOct 2023Wezlana, ustekinumab
- FDAMay 2024Bkemv, eculizumab
- EMAJun 2024Wezenla, ustekinumab
- FDAAug 2024Pavblu, aflibercept
- EDEOct 2024Wezenla, ustekinumab
- HCNov 2024Wezlana, ustekinumab
- EMAApr 2025Pavblu, aflibercept
- HCJul 2025Pavblu, aflibercept
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