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Avastin biosimilar gets unanimous yes from FDA panel

July 14, 2017

An FDA advisory committee today unanimously recommended approval of a biosimilar copy of bevacizumab (Avastin).

The Oncologic Drugs Advisory Committee (ODAC) voted 17-0 to recommend approval of a licensing application from Amgen, which seeks broad indications covered by branded bevacizumab. The requested indications consist of two involving colorectal cancer and one each for non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer.

In explaining their votes, one ODAC member after another cited “compelling” and “impressive” evidence of the biosimilarity of ABP215 to branded bevacizumab. Most of the quibbling revolved around the broad indication request, as several of the indications required extrapolation from experience with other types of cancer. However, several committee members pointed out that extrapolation is common in real-world clinical practice.

“With regard to extrapolation issue, I understand the concerns,” said ODAC chair Bruce Roth, MD, of Washington University in St. Louis. “We extrapolate every day in the clinic. There are things listed in the USP, that are listed in NCCN criteria, that would never have sufficient evidence to get an approval past the agency, and yet there is evidence of some benefit, and that’s sufficient for many oncologists to make that leap of faith. I think the magnitude of the extrapolations here are no greater than we experience on a daily basis.”

ODAC will reconvene later today to consider an application for a biosimilar to trastuzumab (Herceptin). MedPage Today will report the outcome as it becomes available. Although the FDA is not bound by advisory committee recommendations, the agency follows the recommendations more often than not.

http://bit.ly/2taf1qE

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