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Gotenfia (golimumab)

Region

🇪🇺 EU

Active substance

golimumab

Company

Stada Arzneimittel AG

Status

Authorised

Therapeutic area

Arthritis, Rheumatoid; Arthritis, Juvenile; Arthritis, Psoriatic; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Colitis, Ulcerative

CHMP opinion

Thu 11 Dec 2025

EU approval

Tue 10 Feb 2026

Designations

Biosimilar, Additional monitoring

Application

EMEA/H/C/006621

ATC

L04AB06

Official record

www.ema.europa.eu

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 combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Golimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Gotenfia is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-Axial SpA) Gotenfia is indicated for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Gotenfia is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis (pUC) Gotenfia is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Gotenfia in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.

Regulatory milestones

Same substance in other markets

• 🇪🇺 Gobivaz Authorised · Advanz Pharma Limited
• 🇺🇸 Immgolis Approved · Accord Biopharma Inc.
• 🇪🇺 Simponi Authorised · Janssen Cilag International NV

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.