Coherus Submits 351(K) BLA Application to FDA for Pegfilgrastim Biosimilar

Coherus Biosciences, Inc. announced submission to the FDA of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.  Pegfilgrastim is used to prevent or treat neutropenia, a disorder wherein a patient is more susceptible to infection due to chemotherapy.  Coherus supported its 351(k) application with similarity data from analytical, pharmacokinetic, pharmacodynamic, and immunogenicity studies comparing CHS-1701 and Neulasta.

Coherus’s announcement further alluded to a potential future Avastin® biosimilar to increase its presence in the oncology field.   Stay tuned to the Big Molecule Watch Blog for further developments.