Date: 31-Jul-2019

Pfizers Rituxan biosimilar bags FDA approval

The treatment has been approved in adult patients with non-Hodgkins lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of Ruxience to Rituxan, including results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of the biosimilar and found no clinically meaningful differences in safety or efficacy in patients with CD20-positive, low tumour burden follicular lymphoma.