Korea approves Samsung's Remicade biosimilar

Samsung Bioepis Co. Ltd. said South Korea's Ministry of Food and Drug Safety (MFDS) approved Renflexis ( SB2), a biosimilar of autoimmune drug Remicade infliximab from Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ). Merck, which holds Korean commercialization rights to Renflexis under a 2013 deal, plans to launch the drug in 1H16.

MFDS approved Renflexis to treat rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis. ...