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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) · Commercial partner or holder: Reliance Life Sciences · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
GolimumabmoleculeReliance Life Sciencesdeveloper1 of 7markets0trials behind it13other products, same developer0rival developers in its markets

About Reliance Life Sciences golimumab

Reliance Life Sciences received the first golimumab permission in the world, in India in April 2023, for rheumatoid arthritis, with further uses added in 2024. It was two and a half years ahead of the first European approval.

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

Not listed by PMDA.

HC

Canada

Not listed by HC.

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
Remarks
First golimumab biosimilar permitted anywhere.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Same developer, other molecules

Other biosimilars in the Atlas developed by Reliance Life Sciences: Reliance Life Sciences adalimumab, Reliance Life Sciences bevacizumab, Reliance Life Sciences darbepoetin alfa, Reliance Life Sciences denosumab, Reliance Life Sciences etanercept, Reliance Life Sciences follitropin alfa, Reliance Life Sciences infliximab, Reliance Life Sciences omalizumab, Reliance Life Sciences ranibizumab, Reliance Life Sciences rituximab, Reliance Life Sciences somatropin, Reliance Life Sciences trastuzumab, UstekiRel.

Chronology

Sources

All golimumab biosimilars

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Data current to September 2026.