As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its Mylan-Biocon’s aBLA.
This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. 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).
Stay tuned to the Big Molecule Watch for further developments.