Coherus plans to resubmit BLA for Neulasta biosimilar

In its FY17 earnings, Coherus BioSciences Inc. (NASDAQ:CHRS) said it will resubmit a BLA for CHS-1701, with plans to launch the product in the U.S. next half. The company, which in November had said it would resubmit the BLA this quarter, declined to provide details. CHS-1701 is a biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Chairman, President and CEO Dennis Lanfear said on a conference call on March 8 Coherus has completed meetings with FDA.

Coherus lost 24% to $15.73 on June 12, 2017 after FDA issued a complete response letter for CHS-1701. The CRL requested in part a reanalysis of a subset of samples for the Phase I CHS-1701-04 trial using an assay with greater sensitivity (see BioCentury, June 14, 2017)...