BioCentury
ARTICLE | Company News

FDA panel to discuss Avastin, Herceptin biosimilars

June 6, 2017 11:48 PM UTC

FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet on July 13 to discuss separately BLAs for biosimilars ABP 215 and MYL-1401O.

Amgen Inc. (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) share rights to ABP 215, a proposed biosimilar for Avastin bevacizumab. The candidate's user fee action date is Sept. 14...