FDA reviewing Herceptin biosimilar from Mylan, Biocon

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said FDA accepted for review a BLA for Myl-1401O, their proposed biosimilar of Herceptin trastuzumab to treat HER2-positive breast cancer. The BsUFA date is Sept. 3. Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit market Herceptin to treat HER2-positive breast and gastric cancers.

Myl-1401O is also under EMA review. The mAb against HER2 is one of six biosimilars Mylan and Biocon are co-developing (see BioCentury Extra, Aug. 25, 2016)...