CHMP Issues Positive Opinion on Samsung Bioepis’ Flixabi, a Biosimilar Treatment for IBD

CHMP Issues Positive Opinion on Samsung Bioepis’ Flixabi, a Biosimilar Treatment for IBD
The Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency, has issued a positive opinion on Samsung Bioepis’ Flixabi for the treatment of ulcerative colitis (UC) and Crohn’s disease, and for rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis. Flixabi (SB2) is a biological product similar to the reference product Remicade (infliximab), and the second anti-TNF-α drug developed by the company receiving a positive opinion for approval in Europe. The active substance of Flixabi is infliximab, an immunosuppressant. Infliximab is a chimeri
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