Home/Biosimilar Atlas/Golimumab/Gobivaz / Gotenfia

Gobivaz / Gotenfia

Golimumab biosimilar developed by Alvotech, development code AVT05. Reference product Simponi (Simponi Aria intravenous in the United States).

Brands by market: Gobivaz (EU, Advanz); Gotenfia (EU, Stada) · Commercial partner or holder: Advanz Pharma (EU); Stada (EU) · Company profile

FDANot listed

EMANov 2025authorised

MHRALicenseddate not shown

PMDANot listed

HCNot listed

CDSCONot listed

EDENot listed

Approved or registered in 2 of 7 markets

Connections

Golimumabmolecule Alvotechdeveloper 2 of 7markets 2trials behind it 4other products, same developer 0rival developers in its markets

About Gobivaz / Gotenfia

Alvotech's golimumab was the first golimumab biosimilar approved outside India, in Europe in November 2025 as Gobivaz through Advanz, with a second name, Gotenfia, through Stada in early 2026. It has not yet been filed in the United States.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Gobivaz

European Medicines Agency and European CommissionApproved

Brand

Gobivaz

Holder or applicant

Advanz Pharma Limited

Pathway

Centralised (Article 10(4))

Approved

Nov 2025

Application or permission

EMEA/H/C/006560

Indications as licensed

RA, PsA, axSpA, UC, pJIA

Presentations

see SmPC

Remarks

First golimumab biosimilar authorised anywhere outside India.

Source

S017 (EMA) · checked Sep 2026

EMA

European Union · Gotenfia

European Medicines Agency and European CommissionApproved

Brand

Gotenfia

Holder or applicant

Stada Arzneimittel AG

Pathway

Centralised (Article 10(4))

Approved

Feb 2026

Application or permission

EMEA/H/C/006621

Presentations

see SmPC

Source

S017 (EMA) · checked Sep 2026

MHRA

United Kingdom · Gobivaz

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Gobivaz

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

50 mg and 100 mg syringes and pens

Source

S023 (MHRA Products) · checked Sep 2026

MHRA

United Kingdom · Gotenfia

Medicines and Healthcare products Regulatory AgencyApproved

Brand

Gotenfia

Holder or applicant

Not shown in the MHRA substance list

Pathway

UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)

Approved

not published

Presentations

50 mg syringe

Source

S023 (MHRA Products) · checked Sep 2026

PMDA

Japan

Not listed by PMDA.

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Gobivaz / Gotenfia by development code, brand or developer. Registry data, sponsor-entered.

Candidate	Developer or sponsor	Reference product	Phase	Design	Registry status	Started	Primary completion	Registry record
AVT05	Alvotech	Simponi	Phase 1	Comparative PK	Completed	Dec 2022	Oct 2023	NCT05632211
AVT05	Alvotech	Simponi	Phase 3	Comparative efficacy	Completed	Mar 2023	Mar 2024	NCT05842213

Same developer, other molecules

Other biosimilars in the Atlas developed by Alvotech: Afiveg / Mynzepli, Selarsdi / Uzpruvo / Usgena, Simlandi / Hukyndra / Libmyris, Zvogra / Kefdensis / Xbonzy / Acvybra.

Chronology

EMANov 2025Authorised by the European Commission as Gobivaz
EMAFeb 2026Authorised by the European Commission as Gotenfia

Sources

S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)

All golimumab biosimilars

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Data current to September 2026.