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CHMP Okays Samsung's Infliximab Biosimilar

This article was originally published in Scrip

Executive Summary

Samsung Bioepis' infliximab biosimilar, Flixabi, has won a green light from the European Medicines Agency's Committee for Medicinal Products for Human Use. The CHMP is recommending it be approved for a range of indications: rheumatoid arthritis, adult and pediatric Crohn's disease, ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.