Posted by Michael Wonder on 11 Jan 2017
U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar trastuzumab
11 January 2017 - If approved, MYL-1401O has potential to be the first biosimilar trastuzumab in the U.S.
Mylan and Biocon today announced that the U.S. 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 is 3 September 2017.
