Amgen’s Mvasi biosimilar is approved.
Federal regulators announced the approval of the first biosimilar treatment for multiple types of cancer earlier this month. Developed by Amgen, Mvasi (bevacizumab-awwb) is the biosimilar of Genentech’s Avastin (bevacizumab), approved in 2004. Mvasi, said FDA is approved to treat a variety of cancers including certain metastatic colorectal cancers, non-small, non-squamous lung cancer, and similar brain, kidney and cervical cancers after surgery and in combination with other standard therapies.
According to FDA, its approval of Mvasi was based on a review of evidence that regulators explained included “extensive structural and functional characterization,” as well as animal study data, pharmaocokinetic and pharmacodynamic data, clinical immunogenicity and clinical, safety and effectiveness data to demonstrate Mvasi’s biosimilarity to Avastin.
“Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, said FDA commissioner Scott Gottlieb, “is an important way to help spur competition that can lower healthcare costs and increase access to important therapies.” Known for slowing the growth in the rising overall trend line of drug prices over the three decades, Gottlieb projected a similar trajectory for large-molecule generics. “We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly,” he continued, “through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”
Approved as a biosimilar, Mvasi is not, said the FDA, an interchangeable product. The agency explained biological products can come from many sources. It is accepted that a biosimilar is a biological product that is approved from data showing that it is “highly similar” to an already approved biologic product and has “no clinically meaningful” differences in terms of safety and efficacy to a previously approved product.