On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan and Biocon’s MYL-1401O product is currently sold in 11 markets worldwide. Trastuzumab is indicated for the treatment of a particular subset of breast cancer.- On November 3, Mylan and Biocon announced that the European Medicines Agency accepted Mylan’s application for approval to market insulin glargine. According to the Mylan press release, the European filing is the partnership’s third to be accepted by the EMA in 2016.
We have previously reported on the Mylan-Biocon partnership, most recently here.