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)...
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