AMGEN and ALLERGAN plc. have submitted a Biologics License Application to 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 said they believe this submission is the first bevacizumab biosimilar application submitted to FDA.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
