Amgen’s RIABNI wins FDA approval for multiple disorders

 

• Amgen (NASDAQ:AMGN) announces that FDA has approved its RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab) for the treatment of adults with Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis (Wegener's Granulomatosis), and Microscopic Polyangiitis.
• RIABNI, a CD20-directed cytolytic antibody, will be available in the U.S. from January 2021, with the Wholesale Acquisition Cost at 23.7% lower than Rituxan and comparable to Ruxience®, another Rituxan-biosimilar.
• The approval was based on data from a randomized, double-blind, comparative clinical study, conducted to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of RIABNI compared to Rituxan.
• https://seekingalpha.com/news/3645524-amgen-s-riabni-wins-fda-approval-for-multiple-disorders