Celltrion grants Remsima marketing rights to Mundipharma

Celltrion Inc. (KOSDAQ:068270) subsidiary Celltrion Healthcare Hungary Kft granted Mundipharma International Ltd. (Cambridge, U.K.) exclusive distribution rights to market Remsima infliximab in the U.K., Germany, Italy, Belgium and Luxembourg. Remsima is a biosimilar of Remicade from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). The humanized mAb against tumor necrosis factor (TNF) alpha is indicated for Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is approved in the EU, Canada, Japan and Korea.

Celltrion submitted an application to FDA for Remsima earlier this month. It was the first application for a biosimilar mAb to be submitted in the U.S. (see BioCentury Extra, Aug. 11). ...