FDA Approves Mvasi, First Bevacizumab Biosimilar

The FDA has announced the approval of Amgen’s bevacizumab biosimilar, ABP 215 (Mvasi). It is the first FDA-approved biosimilar of Avastin, which is approved in the United States and European Union for the treatment of patients with unresectable, locally advanced, recurrent, or metastatic non-squamous non—small cell lung cancer (NSCLC), metastatic carcinoma of the colon or rectum, and metastatic renal cell carcinoma.

The biosimilar’s approval was based on a comprehensive data package including analytical, pharmacokinetic, and clinical data that demonstrated that Mvasi and the reference Avastin are highly similar, with no clinically meaningful differences in terms of efficacy, safety, and immunogenicity between the drugs. Clinical data included in Amgen’s Biologics License Application include results from a phase 3 study in patients with NSCLC, which met its primary endpoint of showing clinical equivalence to Avastin.

Sean E. Harper, MD, executive vice president of research and development at Amgen, said that “The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States.” According to David Nicholson, chief research and development officer at Allergan, Amgen's partner in developing the drug, the approval “underscores our joint commitment to bring cancer biosimilars to market to help patients.”

FDA Commissioner Scott Gottlieb, MD, said that “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies.”

Kashyap Patel, MD, medical oncologist at Carolina Blood and Cancer Care, hailed news of the drug's approval, saying, "As a community oncologist, I welcome any additional tool that would provide us an option at a possibly competitive price. The approval of the bevacizumab biosimilar will likely increase access to anti-VEGF [vascular endothelial growth factor] in treatment of approved indications, especially in underinsured patients or patients with very high co-pays...ABP 215 will reduce the cost of treatment for advanced lung cancer, colon cancer, glioblastomas, and ovarian cancer. Oncology practices participating in alternative payment models such as OCM [Oncology Care Model] or third-generation ACOs [accountable care organizations] are more likely to adopt quickly as they are responsible for the overall cost of care and any improvement in overall cost would be an extremely welcome step."

In July, the Oncologic Drugs Advisory Committee voted unanimously in favor of ABP 215’s approval, despite some of the voting members having expressed concerns about the homogeneity of the patient population studied in the clinical trials, and noted that the patients were primarily white and exclusively male.

Amgen and Allergan have also submitted an application to market ABP 215 in the European Union, and are currently awaiting a regulatory decision.

Below, Bruce A. Feinberg, DO, discusses factors that will affect the uptake of biosimilars among community oncologists.