FDA Delays Decision on Trastuzumab Biosimilar MYL-1401O

August 30, 2017 – The FDA has extended its decision deadline by 3 months on a biologics license application (BLA) for MYL-1401O, a trastuzumab biosimilar co-developed by Mylan and Biocon. Under the new timeframe, a final decision is expected on or before December 3, 2017. The companies submitted the BLA to the FDA in November 2016, and the agency had set an action deadline of September 3, 2017. In July 2017, the FDA’s Oncologic Drugs Advisory … (leggi tutto)