CHMP backs Enbrel biosimilar, UCB epilepsy candidate

EMA's CHMP recommended approval of Benepali etanercept ( SB4) from Samsung Bioepis Co. Ltd., a biosimilar of Enbrel etanercept for a host of autoimmune indications. The committee also recommended approval of Briviact brivaracetam ( UCB 34714) from UCB Group (Euronext:UCB) to treat partial-onset seizures in patients with epilepsy aged 16 and older.

CHMP recommended Benepali to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and plaque psoriasis. Samsung Bioepis is a JV between Biogen Inc. (NASDAQ:BIIB) and Samsung Group (Seoul, South Korea). ...