Denosumab BS F
Denosumab biosimilar developed by Fuji Pharma. Reference product Prolia and Xgeva.
About Denosumab BS F
Denosumab BS F is Fuji Pharma's denosumab, the first denosumab biosimilar approved in Japan, in September 2025. It is approved for the higher dose used in cancer patients, against the Japanese reference brand Ranmark. Fuji Pharma is one of the more active Japanese biosimilar developers, with ustekinumab, aflibercept and golimumab in its range.
Status by market
United States
Not listed by FDA.
European Union
Not listed by EMA.
United Kingdom
Not listed by MHRA.
Japan · Denosumab BS 120 mg RM F
Pharmaceuticals and Medical Devices Agency and MHLWApprovedCanada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Same developer, other molecules
Other biosimilars in the Atlas developed by Fuji Pharma: Aflibercept BS NIT, Filgrastim BS F / Mochida, Golimumab BS F, Ustekinumab BS F.
Chronology
- PMDASep 2025Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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