Mylan Announces Submission Of BLA For Proposed Biosimilar Trastuzumab

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. announced submission of Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. FDA through the 351(K) pathway. Trastuzumab is indicated to treat certain HER2-positive breast and gastric cancers.

The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.