BioCentury
ARTICLE | Clinical News

Coherus resubmits BLA for Neulasta biosimilar

May 4, 2018 7:08 PM UTC

Coherus BioSciences Inc. (NASDAQ:CHRS) resubmitted a BLA for CHS-1701, its biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). FDA issued a complete response letter for the biosimilar last year, and Coherus said Thursday that the resubmitted application includes new immunogenicity data from a revised assay (see BioCentury, June 14, 2017).

In March, the company said it planned to launch the biosimilar in 2H18 following the resubmission (see BioCentury, March 16)...