US FDA gives thumbs up to Avastin and Herceptin biosimilars

By Dan Stanton contact

- Last updated on GMT

Image: iStock/RyanKing999
Image: iStock/RyanKing999

Related tags: Monoclonal antibodies

Amgen and Mylan have both received recommendations for their versions of Roche’s monoclonal antibody blockbusters Avastin and Herceptin.

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.”

Related topics: Markets & Regulations, Biosimilars

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