FDA committee to consider first Avastin biosimilar

The Biologics License Application (BLA) for the first biosimilar candidate to the Roche (ROG: SIX) blockbuster cancer drug Avastin (bevacizumab) to be submitted in the USA, is to be reviewed by a Food and Drug Administration (FDA) committee next month.

On July 13, the agency’s Oncologic Drugs Advisory Committee will consider the data supporting ABP 215, one of four oncology biosimilars being developed in a collaboration between US biotech Amgen (Nasdaq: AMGN) and Ireland-incorporated drugmaker Allergan (NYSE: AGN).

The committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with non-squamous non-small cell lung cancer. The trial met its primary endpoint, showing clinical equivalence to the reference product. Safety and immunogenicity were also comparable to bevacizumab.