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DECEMBER 18, 2020

FDA Approves Riabni, Third Biosimilar to Rituxan

By PPN News Staff

The FDA approved rituximab-arrx (Riabni, Amgen), the third biosimilar to U.S.-licensed Rituxan (rituximab, Genentech) for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis. 

Riabni, a CD20-directed cytolytic antibody that has the same amino acid sequence as the reference product, Rituxan, was proven to be highly similar to Rituxan based on a