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The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Flixabi (infliximab), a biosimilar version of Remicade, for approval in Europe, according to a press announcement from Samsung Bioepis. Flixabi is being reviewed by EMA as a treatment for ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
The CHMP’s review of the drug will now be referred to the European Commission (EC), which will decide whether or not to grant marketing authorization for Flixabi. If a marketing authorization is granted, Biogen will commercialize Flixabi in the European Union (EU).
The CHMP review of Flixabi was based on Phase I and Phase III clinical studies that tested the biosimilarity of Flixabi to Remicade. In a 54-week Phase III clinical study, Flixabi showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3% in the Flixabi arm versus 69.2% in the Remicade arm at Week 54, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The Flixabi study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries. Samsung Bioepis currently has a pipeline of thirteen biosimilars.
Source: Samsung Bioepis