Coherus Resubmits Biologics License Application for Pegfilgrastim Biosimilar

This week, biosimilar developer Coherus announced that it has resubmitted a Biologics License Application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate referencing Neulasta.

“The CHS-1701 BLA resubmission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan. Pegfilgrastim is the largest selling oncology product in the [United States], and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data,” said Denny Lanfear, president and CEO of Coherus Biosciences in a statement to investors.

In June 2017, Coherus announced that the FDA had issued a Complete Response Letter (CRL) for its proposed pegfilgrastim biosimilar, requesting that the company perform a reanalysis of a subset of samples with a revised immunogenicity assay as well as additional manufacturing information.

The newly submitted BLA is supported by data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 with the reference product. The updated application also integrates the requested immunogenicity data requested by the FDA.

This resubmission is the latest in a streak of good news for Coherus’ pegfilgrastim candidate. In March, a Delaware court judge granted Coherus’ motion to dismiss a lawsuit brought by Amgen over alleged infringement of a patent covering the reference pegfilgrastim. The patent that was disputed, US patent 8,273,707, covered a process for purifying proteins during which 2 specific salts are used in a loading solution.

According to the court, Amgen previously acknowledged that Coherus did not “literally infringe” on the patent, and “the facts in the prosecution history here are undisputed.”

The company hopes to launch the biosimilar in the US market by mid-2018 and is also anticipating approval for the drug from the European Medicines Agency in the second half of this year.