The company said the decision to restructure follows on from the US Food and Drug Administration’s (FDA) complete response letter (CRL) regarding a licensing application for the biosimilar version of Amgen’s cancer drug Neulasta (pegfilgrastim).
The Biosimilar License Application (BLA) for CHS-1701, or pegfilgrastim, was rejected in its present form on June 12.
In the letter, the FDA said Coherus needs to reanalyse certain patient data. The agency also asked the firm to provide additional manufacturing information.
In a statement released on the same day, Coherus said it planned to work with the FDA to address the information requests.
The firm has been gearing three late-stage clinical products towards commercialisation: CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar).
Coherus did not respond to our request for comment.
When reporting the delay, CEO Danny Lanfear said, “The recent pharmacokinetic/pharmacodynamics (PK/PD) study is acceptable to support filing the BLA. However, given the low cost and relatively short delay involved, it is most prudent to initiate a follow-on study in healthy volunteers.”
“We believe this will remove any residual uncertainty, reduce regulatory risk and potential for BSUFA [biosimilar user fee act] timeline delays, and ultimately increase the likelihood of first cycle approval of CHS-1701,” he said.
Coherus is not the only developer to have a pegfilgrastim biosimilar rejected in the US.
Last year the FDA rejected Sandoz’s biosimilar version of Amgen’s Neulasta.
Sandoz’s parent company Novartis said at the time, “Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate Neulasta. We are working with the agency to address remaining questions.”
Sandoz’s pegfilgrastim candidate is yet to be approved by the FDA.