Big Molecule Watch
June 6, 2017

FDA Advisory Committee to Hold Public Meetings on Amgen’s Proposed Bevacizumab Biosimilar and Mylan’s Proposed Trastuzumab Biosimilar


The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications.  During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the committee with discuss Mylan’s proposed biosimilar of Genentech’s HERCEPTIN (trastuzumab).  FDA established docket FDA-2017-N-2732 for public comment on this meeting.  Comments received on or before June 26, 2017 will be provided to the committee.  Comments received by July 10, 2017 will be taken into consideration by the FDA.