Coherus BioSciences Re-Submits BLA for Neulasta (Pegfilgrastim) Biosimilar Candidate

CP Staff
CP Staff
  • Coherus received a complete response letter from th FDA in June 2017
  • Competitors Mylan and Biocon received a CRL in October of 2017
  • Neulasta has generated $20 billion in sales over the last 20 years

Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway.
The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

In June of 2017, Coherus received a complete response letter (CRL) from the FDA for its biologics license application (“BLA”) for CHS-1701. The FDA requested reanalysis of a subset of subject samples with a revised immunogenicity assay. The CRL also included requests for certain additional manufacturing related process information.

Mylan and Biocon are also co-developing a Neulasta biosimilar. In October of 2017 they also received a CRL from the FDA.

Neulasta is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. Neulasta has generated more than $20 billion in sales over the last 5 years.