FDA reviewing Mylan/Biocon biosimilar of Neulasta

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said FDA accepted for review a BLA for MYL-1401H, their proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). The user fee action goal date is Oct. 9.

U.S. sales of Neulasta were $3.9 billion in 2016...