US FDA gives thumbs up to Avastin and Herceptin biosimilars
Earlier this month, the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 17-0 in favour of approving Amgen's candidate ABP 215, a biosimilar of Roche cancer drugs Avastin (bevacizumab).
And on the same day the Committee voted 16-0 in favour of approving Mylan's MYL-1401O, a biosimilar of another Roche biologic Herceptin (trastuzumab).
US Avastin sales were close to CHF 3bn ($3.17bn) last year, while Herceptin sales stood at over CHF 2.5bn.
But despite the FDA recommendations paving the path for possible sales erosion of two of the Swiss firm’s top-selling products, Roche welcomed the news.
“We have long-supported the FDA’s efforts to implement a science-based pathway for the approval of biosimilars,” spokeswoman Anja von Treskow told Biopharma-Reporter.
“Patients’ interests have always been front-and-center for us, and we believe having more treatment options is a good thing for patients. At Roche, our focus continues to be on discovering the next wave of innovative treatments for people with serious diseases who need new options.”
