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US FDA accepts resubmission of Coherus application for Neulasta biosimilar

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.