Mylan, Biocon biosimilar Neulasta under EMA review

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for their proposed biosimilar pegfilgrastim to treat neutropenia. Amgen Inc. (NASDAQ:AMGN) markets the biosimilar's reference product, Neulasta pegfilgrastim.

The partners said data from pharmacokinetic, pharmacodynamic, efficacy, safety and immunogenicity studies of the biosimilar are to be presented in October at the European Society of Medical Oncology (ESMO) meeting. ...