Celltrion seeking Japanese approval of Remicade biosimilar

Celltrion Inc. (KOSDAQ:068270) submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare (MHLW) for Remsima infliximab ( CT-P13), a biosimilar of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and partner Merck & Co. Inc. (NYSE:MRK). Celltrion's biosimilar mAb is partnered with Nippon Kayaku Co. Ltd. (Tokyo:4272) in Japan. Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508), which has Japanese rights to Remicade from J&J, reported Y73.5 billion ($779.8 million) in Japanese sales of the drug for the fiscal year ending March 31, 2013.

The Japanese submission comes on the heels of European approval for the biosimilar -- the first in the region for a biosimilar mAb -- to treat multiple inflammatory conditions. Celltrion's European partner Hospira Inc. (NYSE:HSP) plans to launch the biosimilar as Inflectra in the coming months (see BioCentury Extra, Sept. 10). ...