Coherus resubmits BLA for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) gained $2.20 (17%) to $14.90 on Thursday after resubmitting 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 Extra, June 12, 2017).

In March, the company said it planned to launch the biosimilar in 2H18 following the resubmission (see BioCentury Extra, March 9)...