The U.S. Food and Drug Administration rejected Coherus Biosciences' application to manufacture CHS-1701, a biosimilar version of Amgen Inc.'s Neulasta.
Neulasta helps in the growth of new white blood cells, which protects against the risk of infection following chemotherapy.
In its complete response letter, the regulator 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.
Coherus is also developing CHS-1420, a biosimilar version of Abbvie Inc.'s arthritis drug Humira, which passed a bioequivalence study in March.