Fresenius Kabi
Biosimilar developer, Germany. 5 development products across 5 molecules: adalimumab, denosumab, enoxaparin sodium, pegfilgrastim, tocilizumab.
First approval in the Atlas: Apr 2019, Idacio, adalimumab (EMA)
FDAproducts approved4
EMAproducts approved4
PMDAproducts approved0
HCproducts approved3
CDSCOproducts approved0
EDEproducts registered1
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Adalimumab | Idacio MSB11022 | Dec 2022 | Apr 2019 | · | Oct 2020 | · | Mar 2024 |
| Denosumab | Conexxence / Bomyntra FKS518 | Mar 2025 | Jul 2025 | · | · | · | · |
| Enoxaparin sodium | Elonox | · | · | · | Oct 2022 | · | · |
| Pegfilgrastim | Stimufend MSB11455 | Sep 2022 | Mar 2022 | · | · | · | · |
| Tocilizumab | Tyenne MSB11456 | Mar 2024 | Sep 2023 | · | Oct 2024 | · | · |
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 Fresenius Kabi is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Ustekinumab | Otulfi | EMA | Fresenius Kabi Deutschland GmbH | Sep 2024 | Formycon |
| Ustekinumab | Otulfi | FDA | Fresenius Kabi USA, LLC | Sep 2024 | Formycon |
| Ustekinumab | Otulfi | HC | Fresenius Kabi Canada LTD | Dec 2024 | Formycon |
Chronology
- EMAApr 2019Idacio, adalimumab
- HCOct 2020Idacio, adalimumab
- EMAMar 2022Stimufend, pegfilgrastim
- FDASep 2022Stimufend, pegfilgrastim
- HCOct 2022Elonox, enoxaparin sodium
- FDADec 2022Idacio, adalimumab
- EMASep 2023Tyenne, tocilizumab
- FDAMar 2024Tyenne, tocilizumab
- EDEMar 2024Idacio, adalimumab
- HCOct 2024Tyenne, tocilizumab
- FDAMar 2025Bomyntra, denosumab
- FDAMar 2025Conexxence, denosumab
- EMAJul 2025Bomyntra, denosumab
- EMAJul 2025Conexxence, denosumab
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