30 August 2017 - The US FDA has notified our partner Mylan that they will extend the target action date for their trastuzumab 351(k) application to 3 December 2017 in order to review some of the clarificatory information submitted to them as a part of the application review process. 

This three month extension has no impact on the anticipated timetable for commercialisation of this product in the U.S.

Read Biocon statement