Coherus Receives Complete Response Letter for Pegfilgrastim Biosimilar

Coherus BioSciences announced yesterday that it has been issued a complete response letter by the FDA in response to its biologics license application for CHS-1701, a pegfilgrastim biosimilar candidate referenced on Amgen’s Neulasta, a product that Coherus called the largest-selling oncology biologic in the United States.

In its letter, the agency asked Coherus to perform a reanalysis of a subset of samples with a revised immunogenicity assay and to provide additional manufacturing-related process information. The FDA did not request a clinical study of CHS-1701 in oncology patients, however, and did not indicate that additional process qualification lots would be necessary.

Coherus says that it will work with the agency to address its outstanding concerns. President and CEO of Coherus BioSciences, Denny Lanfear, said, “While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s request for the purpose of obtaining approval for CHS-1701. 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…we anticipate that CHS-1701’s approval will generate significant US healthcare savings while increasing patient access.”

Investors in Coherus may feel less confident than Lanfear, however; after news of the FDA’s letter broke, the company’s stock prices dropped by 27.2% in Monday’s midday trading.

News of this latest biosimilar setback comes just 5 months after Sandoz withdrew its pegfilgrastim product from consideration by the European Medicines Agency after being issued a list of questions by the agency’s Committee for Medicinal Products for Human Use. Sandoz had previously received its own complete response letter from the FDA for the same product.

In the coming months, all industry eyes will be on Mylan and Biocon’s attempt at a pegfilgrastim biosimilar, MYL-1401H. The FDA accepted a Biologics License Application from Mylan in February, and the agency’s goal date set under the Biosimilar User Fee Act is October 9 of this year.