FDA Advisory Committee to review Avastin biosimilar candidate

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

"Amgen has a long and proud heritage in oncology, and we are committed to providing physicians and patients a range of high quality therapeutic options," said Sean E. Harper, Executive Vice President of R&D at Amgen. "We look forward to discussing the comprehensive data package for ABP 215 with the members of the Committee."

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 tumours.

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.