Nippon Kayaku
Biosimilar developer, Japan. 1 development product across 1 molecule: filgrastim.
First approval in the Atlas: Feb 2013, Filgrastim BS NK, filgrastim (PMDA)
FDAproducts approved0
EMAproducts approved0
PMDAproducts approved1
HCproducts approved0
CDSCOproducts approved0
EDEproducts registered0
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Filgrastim | Filgrastim BS NK | · | · | Feb 2013 | · | · | · |
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 Nippon Kayaku is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Adalimumab | Adalimumab BS CTNK | PMDA | Nippon Kayaku (Celltrion) | Sep 2023 | Celltrion |
| Bevacizumab | Bevacizumab BS CTNK | PMDA | Nippon Kayaku (Celltrion) | Sep 2022 | Celltrion |
| Infliximab | Infliximab BS NK | PMDA | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Jul 2014 | Celltrion |
| Trastuzumab | Trastuzumab BS NK | PMDA | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Mar 2018 | Celltrion |
Chronology
- PMDAFeb 2013Filgrastim BS NK, filgrastim
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.