The U.S. Food and Drug Administration accepted the resubmission of the biologics license application for Coherus Biosciences Inc.'s biosimilar of Amgen Inc.'s Neulasta.
A biosimilar is a biological medicine that is highly similar to and has no clinically meaningful differences from an existing FDA-approved brand-name biologic medicine.
The FDA previously rejected the company's application for CHS-1701 and asked Coherus to reanalyze samples from a subset of patients for immunogenecity and sought additional manufacturing related process information.
Immunogenecity refers to the ability of a drug or vaccine to stir a response from the patient's immune system.
The agency expects to take an action on the application by Nov. 3.