FDA Accepts Mylan’s Bevacizumab Biosimilar Application

Last week, Mylan announced on its quarterly earnings call that the U.S. FDA has accepted the company’s aBLA for a biosimilar of AVASTIN (bevacizumab), which is now under review with a user fee goal date of December 27, 2020.  Mylan is the fourth biosimilar developer to report the filing of an aBLA for a bevacizumab biosimilar.  The FDA already approved Amgen’s MVASI (bevacizumab-awwb) and Pfizer’s ZIRABEV (bevacizumab-bvzr), both of which launched in the U.S. in 2019.  In addition, Samsung Bioepis announced that the FDA accepted its aBLA for a bevacizumab biosimilar this past November.

Mylan further disclosed on last week’s call that it recently submitted a “European application” for its bevacizumab biosimilar that is “currently in the validation stage with the authorities.”