Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 215, a biosimilar candidate to Avastin® (bevacizumab). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies believe this submission is the first bevacizumab biosimilar application submitted to the FDA.
"ABP 215 is one of four oncology biosimilars in our pipeline, and today's BLA submission is an important milestone as Amgen seeks to expand our oncology portfolio," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer, continuing Amgen's mission of providing patients with vital medicines."
"Allergan is committed to developing safe and effective therapies in certain critical disease areas," said David Nicholson, Chief R&D Officer at Allergan. "The filing of ABP 215 is an important step forward in advancing a potential treatment option for patients with disorders susceptible to VEGF inhibition."
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 3 comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase 3 study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in its portfolio, one which has been approved by the FDA (adalimumab-atto) and eight which are in ongoing development. Allergan is also independently developing biosimilars.