FDA Strikes Off Coherus BioSciences’ New Injector Biosimilar Treatment For Cancer Patients

The FDA issued a Complete Response Letter regarding the Biologics License Application supplement for Udenyca Onbody, Coherus BioSciences Inc’s (NASDAQ:CHRS) on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), solely due to an ongoing review of inspection findings at a third-party filler. 

Coherus markets Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen Inc’s (NASDAQ: AMGN) Neulasta, a prescription medicine used to prevent neutropenia (a lack of certain white blood cells) caused by receiving chemotherapy.