FDA Grants Approval to Bevacizumab-awwb as First Biosimilar for Anticancer Therapy
FDA examination found significant no efficacy or safety differences between bevacizumab-awwb and its reference product .
Bevacizumab-awwb is a recombinant IgG1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits angiogenesis. It is the first biosimilar approved in the US for anticancer therapy.
The FDA based its approval on evidence demonstrating that bevacizumab-awwb has no clinically significant differences from its reference product in terms of structural and functional characterization, data collected from animal studies, pharmacokinetic and pharmacodynamics profiles in humans, immunogenicity, and safety and efficacy data.
Commonly reported adverse events for bevacizumab-awwb include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alterations, rectal hemorrhage, dry skin, lacrimation disorder, back pain, and exfoliative dermatitis.
Bevacizumab-awwb has a boxed warning alerting prescribers and patients to the risk of gastrointestinal perforations, surgery and wound healing complications, and severe or fatal pulmonary, gastrointestinal, central nervous system, and vaginal bleeding.
1. FDA approves first biosimilar for the treatment of cancer [news release]. Silver Spring, MD: US food and Drug Administration. Updated September 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576112.htm. Accessed September 14, 2017.