Amgen and Allergan to discuss data supporting BLA for ABP 215, bevacizumab biosimilar candidate

July 14, 2017 9:54 PM

Amgen and Allergan plc. announced that the companies will discuss data supporting the ABP 215 Biologics License Application (BLA) with the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA).

ABP 215 is a biosimilar candidate to Avastin® (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA.

“Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Today, we’re looking forward to discussing the comprehensive data package for ABP 215, Amgen’s first prospective oncologic biosimilar, with the FDA advisory committee.”

During the meeting, Amgen will present a comprehensive data package including the analytical, pharmacokinetic and clinical data, which demonstrate ABP 215 and bevacizumab are highly similar, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products. Clinical studies included results from a Phase 3 study in patients with non-squamous non-small cell lung cancer (NSCLC), which met its primary endpoint of showing clinical equivalence to bevacizumab.

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

“ABP 215 is the first product of our collaboration with Amgen to reach this important milestone,” said David Nicholson, chief R&D officer at Allergan. “If approved, ABP 215 has the potential to provide another high quality treatment option for cancer patients and pave the way for additional high quality oncology biosimilars from Allergan and Amgen.”

The FDA is not bound by the Committee’s recommendation but does takes its advice into consideration when considering the approval of a new therapeutic. The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 14, 2017, for ABP 215.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of 10 biosimilars in its portfolio, one which has been approved by the FDA.

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