ARTICLE | Company News

EMA reviewing first Herceptin biosimilar

August 25, 2016 7:00 AM UTC

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab, to treat HER2-positive breast and gastric cancers. The biosimilar is the first Herceptin biosimilar EMA has accepted for review, and is one of six Mylan and Biocon are co-developing, the partners said.

In June, Mylan and Biocon said the mAb against HER2 met the primary endpoint of bioequivalence to Herceptin in the Phase III HERITAGE study, which compared the compounds as first-line therapies for HER2-positive metastatic breast cancer. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin (see BioCentury Extra, June 3). ...