Blog Big Molecule Watch August 10, 2016

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.