FDA Committee Recommends Approval of Bevacizumab and Trastuzumab Biosimilars

The FDA Oncologic Drugs Advisory Committee (ODAC) unanimously supported biosimilar versions of Roche’s cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab). Amgen and Allergan’s Avastin biosimilar candidate, ABP 215, was reviewed for six of eight of Avastin’s indications. Mylan and Biocon’s Herceptin biosimilar candidate, MYL-1401O, was reviewed for all of Herceptin’s indications.

The ODAC reviewers found no clinically meaningful differences between Roche’s cancer drugs and the biosimilar candidates. Some committee members expressed concern over extrapolating data from different types of cancer, but ODAC chair Bruce Roth, M.D., noted that extrapolation is common practice in clinic.

The target action date for MYL-1401O and ABP 215 are September 3, 2017, and September 14, 2017, respectively.

Big molecule watch will continue to follow these and other biosimilar applications, so check back for further news and updates.