Infliximab regulatory update

Celltrion said Turkey’s Ministry of Health approved Remsima infliximab, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) and partner Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.). Celltrion said the biosimilar is approved for rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis and psoriatic arthritis and expects to launch the drug next quarter. Celltrion plans to market it in the country with Mustafa Nevzat Pharmaceuticals, which Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) acquired in June 2012 (see BioCentury, June 18, 2012). Remicade is a chimeric mAb against tumor necrosis factor (TNF) alpha. ...