EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi
Samsung Bioepis and partner Biogen (Nasdaq: BIIB) said the European Commission has approved Flixabi, a biosimilar version of Johnson & Johnson (NYSE: JNJ) and Merck & Co’s (NYSE: MRK) Remicade (infliximab).
Flixabi is indicated as a treatment for rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Alpna Seth, global head of the biosimilars business unit at Biogen said: “The approval of Flixabi marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercializing biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn’s disease and ulcerative colitis.”
Flixabi will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for Benepali (etanercept), a biosimilar copy of Amgen’s (Nasdaq: AMGN) Enbrel.
At an estimated $10 billion a year, anti-TNF therapies are among the EU’s largest drug expenditures, the companies said in a joint statement.
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