In an historic event, the US Food and Drug Administration (FDA) has approved a biosimilar version of Roche’s cancer treatment Avastin (bevacizumab). Mvasi (bevacizumab-awwb) is the first biosimilar to be approved in the US as a cancer therapy.
Codeveloped by Amgen and Allergan, Mvasi has been approved to treat all five indications of its branded reference product. In most cases, the drug has been approved as an adjunct therapy to chemotherapy or treatment with interferon alfa.
“The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States,” said Dr. Sean E. Harper, executive vice president of Research and Development at Amgen. “With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and Mvasi has the potential to advance access to high-quality, targeted cancer therapy.”
The biosimilar is approved to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma and cervical cancer. While clinical data supported the drugmakers’ claim that Mvasi is highly similar to Avastin, the FDA did not approve it as an interchangeable product.
This means that pharmacists cannot automatically substitute the biosimilar for the branded product without consulting with the prescribing physician. Pharmacists regularly fill patients’ prescriptions for name-brand drugs with their generic counterparts due to cost-savings.
“Mvasi is the first product from our collaboration with Amgen to be approved by the FDA and underscores our joint commitment to bring cancer biosimilars to market to help patients,” said David Nicholson, chief research and development officer at Allergan. “We are committed to developing safe and effective therapies in critical disease areas, and Mvasi is leading the way for additional oncology biosimilars from Amgen and Allergan.”
Avastin is currently one of Roche’s top-selling drugs, and until now, the company has avoided biosimilar competition for the cancer biologic. In 2016, total sales of the drug were 6.78 billion Swiss Francs, or just over $7 billion.
Late last year, Amgen and Allergan submitted Mvasi for review by the European Medicines Authority (EMA). So far, the companies have not released the list price for Mvasi, but it’s likely to be significantly less expensive than Avastin.
“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,” said FDA Commissioner Dr. Scott Gottlieb. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”