Samsung Bioepis Enters the European Biopharmaceutical Market with Benepali®, the First Fusion Protein Biosimilar Approved by the European Commission

Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Benepali® – a biosimilar referencing Enbrel® (etanercept), also known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. The EC approval follows a positive opinion on Benepali® by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which was announced on November 20, 2015.