ARTICLE | Company News

Coherus submits BLA for Neulasta biosimilar

August 9, 2016 7:00 AM UTC

Coherus BioSciences Inc. (NASDAQ:CHRS) said it submitted a BLA to FDA for CHS-1701, its proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Next quarter, Coherus expects to submit an MAA to EMA for the biosimilar.

Coherus said last month that CHS-1701 met the co-primary pharmacodynamic and pharmacokinetic endpoints in a Phase I study that compared the biosimilar to Neulasta (see Biocentury Extra, July 11). ...