Mylan submits Herceptin biosimilar to FDA

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said Mylan submitted a BLA to FDA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab, to treat HER2-positive breast and gastric cancers.

In June, Mylan and Biocon said the mAb against HER2 met the primary endpoint of bioequivalence to Herceptin in a Phase III study. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin (see BioCentury Extra, June 3)...