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Korea approves Celltrion's Herceptin biosimilar

January 16, 2014 12:47 AM UTC

Celltrion Inc. (KOSDAQ:068279) said South Korea's Ministry of Food and Drug Safety (MFDS) approved Herzuma trastuzumab as a biosimilar of Herceptin trastuzumab to treat early and advanced HER2-positive breast cancer and advanced stomach cancer. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin, a humanized mAb against HER2. Celltrion said it plans to launch Herzuma in Korea this half but did not specify a price for the biosimilar. According to the company, Korean sales of Herceptin are about $80 million annually.

Herzuma is the first approved biosimilar of Herceptin in Korea and Celltrion's second approved biosimilar in the country. In 2012, MFDS approved Celltrion's Remsima infliximab, a biosimilar of Remicade infliximab from Johnson & Johnson (NYSE:JNJ). In September, Remsima became the first biosimilar mAb to gain European approval (see BioCentury Extra, Sept. 10, 2013). ...