ABP 215 (bevacizumab biosimilar) filed with FDA for non-small cell lung cancer- Amgen/Allergan

Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the U.S. FDA for ABP 215, a biosimilar candidate to Avastin (bevacizumab). ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase III comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase III study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.