Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license application for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
We will work closely with the FDA to bring this important medicine to patients in the U.S.
We do not expect this to impact our U.S launch plan.
