Coherus gets CRL for Neulasta biosimilar

Coherus BioSciences Inc. (NASDAQ:CHRS) said FDA issued a complete response letter for CHS-1701, the company's proposed biosimilar of neutropenia drug Neulasta pegfilgrastim from Amgen Inc. (NASDAQ:AMGN). Neulasta is a pegylated G-CSF.

On a conference call, Chairman, President and CEO Denny Lanfear said the agency requested a reanalysis of a subset of samples from the Phase I CHS-1701-04 trial using an assay with "improved sensitivity," which the company will develop based on FDA's recommendations. EVP of Global Regulatory Affairs Lisa Bell declined to disclose further information about the subset, but said the number of samples to be processed is "well within our capability."...