Ustekinumab BS F
Ustekinumab biosimilar developed by Fuji Pharma. Reference product Stelara.
About Ustekinumab BS F
Ustekinumab BS F is Fuji Pharma's ustekinumab, the first ustekinumab biosimilar approved in Japan, in September 2023, for psoriasis and psoriatic arthritis. A second strength was added in 2026. Fuji Pharma has not named the developer of the product.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan · Ustekinumab BS F
Pharmaceuticals and Medical Devices Agency and MHLWApprovedCanada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Ustekinumab BS F holds an approval, these are the other ustekinumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| PMDA | 3 | Celltrion (Steqeyma), Nipro (Ustekinumab BS Nipro), Yoshindo (Ustekinumab BS YD) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Fuji Pharma: Aflibercept BS NIT, Denosumab BS F, Filgrastim BS F / Mochida, Golimumab BS F.
Chronology
- PMDASep 2023Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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