FDA approves Renflexis, second infliximab biosimilar

April 23, 2017 1:23 PM


South Korea’s Samsung Bioepis has won a U.S. FDA approval for a biosimilar of Johnson & Johnson’s Remicade, marking a first for the company in the U.S., CNBC reports.

Samsung Bioepis, a partnership with Biogen, won U.S. approval for Renflexis, which is a version of infliximab referred to as a biosimilar because it is not an exact chemical copy like a generic drug.

The biosimilar therapy is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis.

The FDA approval sets up a complex game of marketing with Merck handling sales of Remicade in Europe, while Samsung has a version called Flixabi approved by the European Medicines Agency last year that is marketed by Biogen in Europe.

But Merck will handle marketing for Renflexis in the U.S. and compete against another biosimilar of Remicade from Pfizer called Inflectra.

In another aspect on biosimilars, the U.S. Supreme Court could decide by this summer on whether to keep a 180-day waiting period in place before makers of biologic drugs can launch sales after approvals.

Source: CNBC

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