Golimumab BS F
Golimumab biosimilar developed by Fuji Pharma. Reference product Simponi (Simponi Aria intravenous in the United States).
Brands by market: Golimumab 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 · Golimumab BS F
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Golimumab BS F
Holder or applicant
Fuji Pharma
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Sep 2025
Indications as licensed
Rheumatoid arthritis
Presentations
50 mg syringe
Note
Golimumab Biosimilar 1, the first golimumab biosimilar approved outside India.
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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