BioCentury
ARTICLE | Company News

Coherus gains on plans to resubmit BLA for Neulasta biosimilar

March 9, 2018 11:44 PM UTC

Coherus BioSciences Inc. (NASDAQ:CHRS) rose $2.75 (30%) to $11.85 on Friday after announcing in its earnings that 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 late Thursday 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 Extra, June 12, 2017)...