EMA Authorised: Fubelv — Biosimilar Collaborations Ireland Limited

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Summary

EMA has authorised Fubelv as a biosimilar, with indications across various inflammatory arthritis and psoriasis conditions.

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Diseases / indications

• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Juvenile Idiopathic Arthritis
• Non-radiographic Axial Spondyloarthritis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis

Drugs mentioned

• Fubelv

Snippet

Status: Authorised. Therapeutic area: Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Non-Radiographic Axial Spondyloarthritis;Spondylitis, Ankylosing;Psoriasis. MAH: Biosimilar Collaborations Ireland Limited. Decision date: 11/06/2026