Celltrion’s Remsima (infliximab) receives marketing approval in Japan

Celltrion’s RemsimaTM (infliximab) receives marketing approval in Japan - Last year sales of originator drug in Japan totaled approximately KRW 1 trillion...Japan, the second largest market after the US Celltrion, Inc. (KOSDAQ: 068270) announced today that the company has received marketing authorization for its autoimmune disease treatment biosimilar mAb RemsimaTM (infliximab) from the Japan's Ministry of Health, Labour and Welfare (MHLW). With this latest marketing authorization in Japan, excluding the USA, RemsimaTM has now received approval from the majority of advanced nations (such as Europe and Canada) by passing regulations imposed by said nations and these approvals effectively open up for sales half of the entire market for Remsima’s originator drug infliximab. Celltrion expects flexibility with sales with the launch of RemsimaTM into the Japanese market and with the originator drug patent expiry for the big 5 European countries early next year. In addition, Celltrion anticipates submitting marketing authorization approval for RemsimaTM in the USA in the latter half of this year. An official from Celltrion explained, “Japan is the one of the most advanced regulatory agencies which is known to have strict regulations and requires additional clinical trials in their own country. Celltrion's superior technology and development ability and RemsimaTM's high quality and efficacy were proven once again by this momentous Japanese approval."

The release as fetched from its publisher. celltrion.com ↗