FDA Advisory Committee to review BLA for ABP 215 (bevacizumab biosimilar) on 13 July 2017.- Amgen + Allergan

Amgen and Allergan plc have announced that the Oncologic Drugs Advisory Committee of the FDA will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab), on 13 July 2017.

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 (NSCLC). The Phase III study met its primary endpoint showing clinical equivalence to bevacizumab. Safety and immunogenicity of ABP 215 were also comparable to 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 FDA has set a Biosimilar User Fee Act (BsUFA) target action date of 14 September 2017 , for ABP 215. Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one which has been approved by the FDA .