Christopher Hansung Ko
Samsung Bioepis’ Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union
Samsung Bioepis’ Flixabi® receives positive opinion from the Committee for Medicinal Products for Human Use, meets the European Medicines Agency’s requirements on the quality, efficacy and safety of biosimilars Flixabi® […]
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.
Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the second regulatory approval for Samsung Bioepis in Korea. The MFDS approved in September 2015 Samsung Bioepis’ BRENZYS®, a biosimilar version of Enbrel® (etanercept), also known as SB4.