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 · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDASep 2025approved
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Golimumab BS F

Golimumab BS F is Fuji Pharma's golimumab, approved in Japan in September 2025 for rheumatoid arthritis, the first golimumab biosimilar in Japan and, at the time, the first anywhere outside India. Fuji Pharma has not named the developer.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan · Golimumab BS F

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
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
Remarks
Golimumab Biosimilar 1, the first golimumab biosimilar approved outside India.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Same developer, other molecules

Other biosimilars in the Atlas developed by Fuji Pharma: Aflibercept BS NIT, Denosumab BS F, Filgrastim BS F / Mochida, Ustekinumab BS F.

Chronology

Sources

All golimumab biosimilars

Planning golimumab biosimilar development?

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 consultant
Data current to September 2026.