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FDA Approves Rituximab Biosimilar


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On July 24, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr -(Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangi-itis. Rituximab-pvvr is a monoclonal antibody biosimilar to rituximab; it works by targeting the protein CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.

The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of rituximab-pvvr to rituximab. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of rituximab-pvvr and found no clinically meaningful differences in safety or efficacy compared with the reference product in patients with CD20-positive, low–tumor burden follicular lymphoma. 


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