The FDA denied approval of Coherus BioSciences’ biologics license application for CHS-1701, a proposed biosimilar for pegfilgrastim.
Like pegfilgrastim (Neulasta, Amgen), CHS-1701 is designed to reduce the chance of infection due to low white blood cell count among patients with nonmyeloid malignancies who received chemotherapy.
The FDA issued a complete response letter to Coherus that requested a reanalysis of a subset of subject samples with a revised immunogenicity assay. The letter also requests additional manufacturing-related process information, according to a company-issued press release.
The FDA did not request a clinical patient study to be performed, nor did the agency indicate additional process qualification lots would be required.
Coherus officials indicated they intend to work with the FDA to address the information requests pertaining to the biosimilar candidate.
“[Although] we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” Denny Lanfear, president and CEO of Coherus BioSciences, said in the press release.
“We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months,” Lanfear added. “Neulasta is the largest-selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access.”