Sandoz
Biosimilar developer, Switzerland. 10 development products across 10 molecules: adalimumab, aflibercept, denosumab, enoxaparin sodium, epoetin alfa and zeta, etanercept, filgrastim, pegfilgrastim, rituximab, somatropin.
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Adalimumab | Hyrimoz / Hefiya GP2017 | Oct 2018 | Jul 2018 | · | Nov 2020 | · | Oct 2019 |
| Aflibercept | Enzeevu / Afqlir | Aug 2024 | Nov 2024 | · | Oct 2025 | · | · |
| Denosumab | Jubbonti / Wyost GP2411 | Mar 2024 | May 2024 | · | Feb 2024 | · | Jun 2026 |
| Enoxaparin sodium | Inclunox | · | · | · | Nov 2020 | · | · |
| Epoetin alfa and zeta | Binocrit / Epoetin alfa Hexal / Abseamed HX575 | · | Aug 2007 | · | · | · | Sep 2018 |
| Etanercept | Erelzi GP2015 | Aug 2016 | Jun 2017 | · | Apr 2017 | · | Apr 2020 |
| Filgrastim | Zarxio / Zarzio EP2006 | Mar 2015 | Feb 2009 | Mar 2014 | · | · | Mar 2015 |
| Pegfilgrastim | Ziextenzo LA-EP2006 | Nov 2019 | Nov 2018 | · | Apr 2020 | · | Oct 2020 |
| Rituximab | Rixathon / Riximyo GP2013 | · | Jun 2017 | Sep 2017 | Apr 2020 | · | Mar 2019 |
| Somatropin | Omnitrope | · | Apr 2006 | Jun 2009 | Apr 2009 | · | May 2014 |
Month shown is the first approval or registration of that product in that market.
Also holds or markets
Products developed by another company for which Sandoz is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Infliximab | Zessly | EMA | Sandoz GmbH | May 2018 | Pfizer and Sandoz |
| Insulin glargine | Ondibta | EMA | Sandoz GmbH | Jan 2026 | Gan & Lee Pharmaceuticals |
| Natalizumab | Tyruko | FDA | Sandoz Inc. | Aug 2023 | Polpharma Biologics |
| Natalizumab | Tyruko | EMA | Sandoz GmbH | Sep 2023 | Polpharma Biologics |
| Ranibizumab | Cimerli | FDA | Sandoz Inc. | Aug 2022 | Bioeq (Formycon and Polpharma) |
| Trastuzumab | Herwenda | EMA | Sandoz GmbH | Nov 2023 | EirGenix |
Chronology
- EMAApr 2006Omnitrope, somatropin
- EMAAug 2007Abseamed, epoetin alfa and zeta
- EMAAug 2007Epoetin alfa Hexal, epoetin alfa and zeta
- EMAAug 2007Binocrit, epoetin alfa and zeta
- EMAFeb 2009Filgrastim Hexal, filgrastim
- EMAFeb 2009Zarzio, filgrastim
- HCApr 2009Omnitrope, somatropin
- PMDAJun 2009Somatropin BS [Sandoz], somatropin
- PMDAMar 2014Filgrastim BS Sandoz, filgrastim
- EDEMay 2014Omnitrope, somatropin
- FDAMar 2015Zarxio, filgrastim
- EDEMar 2015Zarzio, filgrastim
- FDAAug 2016Erelzi, etanercept
- HCApr 2017Erelzi, etanercept
- EMAJun 2017Rixathon, rituximab
- EMAJun 2017Riximyo, rituximab
- EMAJun 2017Erelzi, etanercept
- PMDASep 2017Rituximab BS [KHK], rituximab
- EMAJul 2018Hefiya, adalimumab
- EMAJul 2018Hyrimoz, adalimumab
- EDESep 2018Binocrit, epoetin alfa and zeta
- FDAOct 2018Hyrimoz, adalimumab
- EMANov 2018Ziextenzo, pegfilgrastim
- EDEMar 2019Rixathon, rituximab
- EDEOct 2019Hyrimoz, adalimumab
- FDANov 2019Ziextenzo, pegfilgrastim
- EDEApr 2020Erelzi, etanercept
- HCApr 2020Ziextenzo, pegfilgrastim
- HCApr 2020Riximyo, rituximab
- EDEOct 2020Ziextenzo, pegfilgrastim
- HCNov 2020Hyrimoz, adalimumab
- HCNov 2020Inclunox, enoxaparin sodium
- HCFeb 2024Jubbonti, denosumab
- HCMar 2024Wyost, denosumab
- FDAMar 2024Jubbonti, denosumab
- FDAMar 2024Wyost, denosumab
- EMAMay 2024Jubbonti, denosumab
- EMAMay 2024Wyost, denosumab
- FDAAug 2024Enzeevu, aflibercept
- EMANov 2024Afqlir, aflibercept
- EMAJul 2025Rolcya, denosumab
- HCOct 2025Enzeevu, aflibercept
- EDEJun 2026Jubbonti, denosumab
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