Coherus eyes marketing go-ahead after positive on-body injector trial

  UDENYCA® On-Body Injector (OBI) Achieved Both Pharmacokinetic and Pharmacodynamic Bioequivalence in Randomized Clinical Trial

- Coherus plans to seek U.S. marketing authorization for the UDENYCA® OBI in 2022

Coherus BioSciences, Inc. (“the Company”; Nasdaq: CHRS) today announced positive results from a randomized, open-label, crossover study assessing the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of UDENYCA® (pegfilgrastim-cbqv) administered via a proprietary on-body injector (OBI) device compared to the currently marketed UDENYCA® pre-filled syringe (PFS). The study met all PK bioequivalence primary endpoints as well as the key secondary pharmacodynamic endpoint of ANC (absolute neutrophil count). No new safety signals were observed. The study enrolled 189 subjects randomized 1:1 to receive one of two treatment sequences of UDENYCA®: OBI followed by PFS, or the reverse, with a treatment interval of 6 to 8 weeks.

Coherus plans a 2022 submission to the United States Food and Drug Administration (FDA) of a prior approval supplement to seek marketing authorization for the UDENYCA® OBI and anticipates a standard 10-month review period. Coherus expects commercial launch of the UDENYCA® OBI directly post approval.

https://finance.yahoo.com/news/coherus-announces-positive-results-udenyca-120000038.html