EMA — authorised 17 November 2025
- Application: EMEA/H/C/006560
- Marketing authorisation holder: Advanz Pharma Limited
- Local brand name: Gobivaz
- Indication: Rheumatoid arthritis (RA) Gobivaz, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Gobivaz (TNFi) on 17 November 2025. Gobivaz is a biosimilar of a tumour necrosis factor inhibitor (TNFi) and is indicated for the treatment of various inflammatory diseases. The approved indications include moderate to severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe ankylosing spondylitis, non-radiographic axial spondyloarthritis, and moderately to severely active ulcerative colitis.
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EMA — authorised 10 February 2026
- Application: EMEA/H/C/006621
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Gotenfia
- Indication: Rheumatoid arthritis (RA)Gotenfia, in combination with methotrexate (MTX), is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.Golimumab, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.Psoriatic arthritis (PsA)Gotenfia, alone or in combina
- Pathway: biosimilar
- Status: approved
The European Medicines Agency (EMA) granted marketing authorisation for Gotenfia (TNFi) on 10 February 2026. Gotenfia is a biosimilar of a tumour necrosis factor inhibitor (TNFi) and is indicated for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, and polyarticular juvenile idiopathic arthritis. Gotenfia is available in combination with methotrexate for some indications and as a monotherapy for others.
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