Tuesday 24 November 2015

SAMSUNG BIOEPIS RECEIVES POSITIVE CHMP OPINION FOR THE FIRST ETANERCEPT BIOSIMILAR IN THE EUROPEAN UNION

INCHEON, Korea, Nov 23 (Bernama-BUSINESS WIRE) -- 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.



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