The FDA has approved bevacizumab-awwb (Mvasi) as a treatment for multiple cancers. The drug has been approved as a biosimilar to its reference biologic, bevacizumab (Avastin), but it has not been approved as an interchangeable product.
The FDA has approved bevacizumab-awwb (Mvasi) as treatment for multiple cancers. The drug has been approved as a biosimilar to its reference biologic, bevacizumab (Avastin), but it has not been approved as an interchangeable product.
Mvasi, developed via a partnership between Amgen and Allergan, is approved for the treatment of adult patients suffering from either colorectal cancer, glioblastoma, cervical cancer, or non-squamous non—small cell lung cancer. Specifically, the approved indications include:
FDA Commissioner Scott Gottlieb, MD, said in a statement, “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." He added that the FDA will continue on its track to bring new biosimilar medications 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.”
The approval follows 2 months after a unanimous (17-0) vote by the FDA’s Oncologic Drugs Advisory Committee to approve the drug.
The evidence submitted for FDA review included structural and functional characterization of bevacizumab-awwb, along with animal study data, pharmacokinetic and pharmacodynamic study data in humans, clinical immunogenicity data, and other safety and efficacy data.
The reference bevacizumab is manufactured by Genentech and was approved in February 2004.
In the following video, Bruce A. Feinberg, DO, discusses the adoption of biosimilars among community oncologists with 's Center for Biosimilars.