Denosumab BS F
Denosumab biosimilar developed by Fuji Pharma. Reference product Prolia and Xgeva.
Brands by market: Denosumab BS F (Japan) · Commercial partner or holder: Fuji Pharma
FDAnot listed
EMAnot listed
PMDASep 2025approved
HCnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union
Not listed by EMA.
PMDA
Japan · Denosumab BS 120 mg RM F
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Denosumab BS 120 mg RM F
Holder or applicant
Fuji Pharma
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2025
Indications as licensed
Bone lesions in multiple myeloma and solid-tumour bone metastasis
Presentations
120 mg vial
Note
Denosumab Biosimilar 1; reference product Ranmark (Xgeva).
Source
S020
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- PMDASep 2025Approved by MHLW
Sources
S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)
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