BioCentury
ARTICLE | Clinical News

EMA's CHMP recommends Celltrion's trastuzumab biosimilar

December 22, 2017 12:13 AM UTC

Celltrion Inc. (KOSDAQ:068270) received a positive recommendation from EMA's CHMP for Herzuma, a biosimilar of cancer drug Herceptin trastuzumab from Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit. The committee recommended approval to treat HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic gastric cancer -- the same approved indications as Herceptin. The European Commission approved the first trastuzumab biosimilar in November (see BioCentury, Dec. 8)...