FDA panel backs approval of Amgen's Avastin biosimilar

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 17-0 in favor of approving ABP 215 from Amgen Inc. (NASDAQ:AMGN). The product is a biosimilar of Avastin bevacizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHBBY).

The committee discussed whether evidence presented by the company and FDA showed that the candidate was “highly similar” and had no “clinically meaningful differences” to its reference product...