Yesterday, Samsung Bioepis and Biogen announced pooled analysis results that will be presented this week at the 2018 Annual European Congress of Rheumatology (EULAR). Data from three separate Phase III randomized, double-blinded studies compared the safety and efficacy of BENEPALI (SB4, etanercept biosimilar); FLIXABI (SB2, infliximab biosimilar); and IMRALDI (SB5, adalimumab biosimilar) in a population of patients with moderate to severe rheumatoid arthritis (RA) despite previous methotrexate treatment. According to the joint press release, the pooled data indicated that the biosimilars were equally as effective as their reference products.
In 2016, the European Commission granted marketing authorization for BENEPALI and FLIXABI, which reportedly have been used to treat nearly 80,000 patients across 23 countries. Pursuant to a license agreement entered earlier this year, Samsung Bioepis and Biogen expect to launch IMRALDI in Europe in October 2018, after having received marketing authorization last summer.
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