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.
An analysis by researchers from the International Agency for Research on Cancer casts doubt on validity of an endpoint used in key studies of multi-cancer detection tests.
