Bio-Thera Solutions
Biosimilar developer, China. 3 development products across 3 molecules: bevacizumab, tocilizumab, ustekinumab.
First approval in the Atlas: Sep 2023, Tofidence, tocilizumab (FDA)
FDAproducts approved3
EMAproducts approved2
PMDAproducts approved0
HCproducts approved0
CDSCOproducts approved0
EDEproducts registered0
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Bevacizumab | Avzivi BAT1706 | Dec 2023 | Jul 2024 | · | · | · | · |
| Tocilizumab | Tofidence / Tocilizumab STADA BAT1806 | Sep 2023 | Jun 2024 | · | · | · | · |
| Ustekinumab | Starjemza BAT2206 | May 2025 | · | · | · | · | · |
Month shown is the first approval or registration of that product in that market.
Chronology
- FDASep 2023Tofidence, tocilizumab
- FDADec 2023Avzivi, bevacizumab
- EMAJun 2024Tocilizumab STADA, tocilizumab
- EMAJul 2024Avzivi, bevacizumab
- FDAMay 2025Starjemza, ustekinumab
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.