Blog Big Molecule Watch March 04, 2020

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.”


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