EMA Authorised: Flixabi (infliximab) — Samsung Bioepis NL B.V.

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Summary

The EMA authorised Flixabi, a biosimilar of infliximab, for several inflammatory diseases. The indications include rheumatoid arthritis, psoriatic arthritis, an…

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Diseases / indications

• Ankylosing Spondylitis
• Crohn Disease
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Ulcerative Colitis

Drugs mentioned

• Flixabi (infliximab)

Snippet

Status: Authorised. Therapeutic area: Arthritis, Psoriatic;Spondylitis, Ankylosing;Colitis, Ulcerative;Arthritis, Rheumatoid;Crohn Disease;Psoriasis. MAH: Samsung Bioepis NL B.V.. Decision date: 19/05/2025