Amgen and Allergan's data supporting their Biologics License Application for ABP 215, a biosimilar candidate to Avastin (bevacizumab), will be reviewed by the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration by July 13.
"Amgen has a long and proud heritage in oncology, and we are committed to providing physicians and patients a range of high quality therapeutic options," Dr. Sean Harper, executive vice president of Research and Development at Amgen, said. "We look forward to discussing the comprehensive data package for ABP 215 with the members of the committee."
According to Amgen, the committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215. Amgen noted that, in the Phase 3 study analyzing the biosimilar’s performance in treating patients with non-squamous non-small cell lung cancer, the drug met its primary endpoint – showing clinical equivalence to bevacizumab. The committee will take into account safety and immunogenicity data, which Amgen states is comparable to bevacizumab.
The FDA has selected Sept. 14 as the Biosimilar User Free Act target action date for ABP 2015.
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