Mingi Hyun
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 Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union
Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali® – a biosimilar version of Enbrel® (etanercept), previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.