Formycon
Biosimilar developer, Germany. 2 development products across 2 molecules: aflibercept, ustekinumab.
First approval in the Atlas: Jun 2024, Ahzantive, aflibercept (FDA)
FDAproducts approved2
EMAproducts approved2
PMDAproducts approved0
HCproducts approved1
CDSCOproducts approved0
EDEproducts registered0
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Aflibercept | Ahzantive / Baiama FYB203 | Jun 2024 | Jan 2025 | · | · | · | · |
| Ustekinumab | Otulfi / Fymskina FYB202 | Sep 2024 | Sep 2024 | · | Dec 2024 | · | · |
Month shown is the first approval or registration of that product in that market.
Chronology
- FDAJun 2024Ahzantive, aflibercept
- EMASep 2024Fymskina, ustekinumab
- EMASep 2024Otulfi, ustekinumab
- FDASep 2024Otulfi, ustekinumab
- HCDec 2024Otulfi, ustekinumab
- EMAJan 2025Ahzantive, aflibercept
- EMAJan 2025Baiama, aflibercept
Considering a partner, a licence or a new market for a biosimilar portfolio? EvySaif's regulatory strategy and value dossier work covers the regulatory and market-access side of that decision.
Planning your biosimilar strategy?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.