Mylan & Biocon: FDA To Review BLA For Proposed Biosimilar Bevacizumab

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. announced the U.S. FDA has accepted Mylan's Biologics License Application for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review. The FDA goal date is Dec. 27, 2020.

Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Bevacizumab is one of the 11 biologic products being co-developed by the companies. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.