FDA Brief: Rituximab Biosimilar Approved for Treatment of CLL
Posted: Monday, January 4, 2021
On December 17, the U.S. Food and Drug Administration (FDA) approved rituximab-arrx (Riabni), a biosimilar to rituximab (Rituxan). It is indicated for the treatment of adults with chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma, granulomatosis with polyangiitis, and microscopic polyangiitis. For patients with CLL, it is indicated in combination with fludarabine and cyclophosphamide for the treatment of adults with previously untreated and previously treated CD20-positive disease. Rituximab-arrx is expected to be made available in the United States early in 2021.
Rituximab-arrx, a CD20-directed cytolytic antibody, was found to be similar to Rituxan based on a totality of evidence, which included comparative analytic, nonclinical, and clinical data, with no clinically meaningful differences in safety or effectiveness. The data package was composed in part, of results from a pharmacokinetic similarity study and a comparative clinical study.
Of note, the label for rituximab-arrx has a boxed warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.
For the full prescribing information, visit accessdata.fda.gov.