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)
FDAnot listed
EMANov 2025authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Gobivaz
European Medicines Agency and European CommissionApprovedBrand
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
Note
First golimumab biosimilar authorised anywhere outside India.
Source
S017
EMA
European Union · Gotenfia
European Medicines Agency and European CommissionApprovedBrand
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
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)
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