Amgen and Allergan plc submitted a Biologics License Application (BLA) to the U.S. FDA for ABP 215, a biosimilar candidate to Roche's 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 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," said Sean E. Harper, M.D., executive vice president of research and development at Amgen.
"The filing of ABP 215 is an important step forward in advancing a potential treatment option for patients with disorders susceptible to VEGF inhibition," said David Nicholson, Chief R&D Officer at Allergan.
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.