Home/Biosimilar Atlas/Golimumab/Reliance Life Sciences golimumab

Reliance Life Sciences golimumab

Golimumab biosimilar developed by Reliance Life Sciences. Reference product Simponi (Simponi Aria intravenous in the United States).

Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Reliance Life Sciences
FDAnot listed
EMAnot listed
CDSCOApr 2023permitted
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Reliance Life Sciences Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Apr 2023
Application or permission
MF/BIO/23/000038; drug substance MF/BIO/23/000047; additional indications MF/BIO/24/000111 (October 2024)
Indications as licensed
Rheumatoid arthritis with methotrexate at permission; further indications added October 2024
Presentations
50 mg/0.5 mL and 100 mg/mL PFS
Note
First golimumab biosimilar permitted anywhere.
Source
S011
EDE

United Arab Emirates

Not listed by EDE.

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.