Mylan N.V. and Biocon Ltd. said FDA has accepted Mylan’s biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway.
This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers. The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Sept 3.
Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by the European Medicines Agency.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.
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.
