BioCentury
ARTICLE | Clinical News

FDA accepts resubmitted Coherus biosimilar BLA for review

May 18, 2018 7:41 PM UTC

Coherus BioSciences Inc. (NASDAQ:CHRS) said FDA accepted for review a resubmitted BLA for CHS-1701, a proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Its BSUFA date is Nov. 3.

FDA issued a complete response letter for the biosimilar last year. The resubmitted application includes new immunogenicity data from a revised assay (see BioCentury, June 14, 2017 & May 4, 2018)...