Coherus to Delay BLA Submission for Neulasta Biosimilar

Coherus BioSciences will delay its planned submission of a BLA for CHS-1701 — a knockoff of Amgen’s Neulasta for treatment of neutropenia — by about three months to conduct an additional pharmacokinetic and pharmacodynamic study.

According to the company, a new study will cost less than $4 million, and was not requested by the FDA.

CHS-1701 met its primary endpoints in a previous study, but missed bioequivalence endpoints due to a "low, anomalous" pharmacokinetic profile in one treatment group, Coherus said in October.