FDA Accepts BLA For Mylan And Biocon' Proposed Biosimilar Trastuzumab

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. announced that the U.S. Food and Drug Administration has accepted Mylan's biologics license application (BLA) 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 September 3, 2017.

Mylan and Biocon's proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).