BioCentury
ARTICLE | Company News

FDA reviewing Coherus' biosimilar of Neulasta

October 7, 2016 7:00 AM UTC

Coherus BioSciences Inc. (NASDAQ:CHRS) said FDA accepted its BLA for CHS-1701, its proposed biosimilar of neutropenia drug Neulasta pegfilgrastim. The action date for the application is June 9, 2017.

Amgen Inc. (NASDAQ:AMGN) markets Neulasta. In July, Novartis AG (NYSE:NVS; SIX:NOVN) said FDA issued a complete response letter for LA-EP2006, its proposed Neulasta biosimilar (see BioCentury Extra, July 19). ...