The Food and Drug Administration has approved RiabniTM (rituximab-arrx; Amgen), a biosimilar to Rituxan (Genentech, Biogen), for the treatment of adults with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA).
Riabni is a CD20-directed cytolytic antibody. Approval was based on a phase 3 comparative study (JASMINE), which enrolled 256 patients and randomized them 1:1 to receive 375mg/m2 intravenous infusion of either Riabni or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20. An assessment of the overall response rate by week 28, was found to be within the prespecified margin for Riabni compared to Rituxan. Pharmacokinetics, pharmacodynamics, safety and immunogenicity of Riabni were found to be similar to Rituxan.
The Company expects Riabni to be available in January 2021.
Murdo Gordon, executive vice president of Global Commercial Operations at Amgen said, “The approval of Riabni represents an important milestone across our biosimilar and oncology portfolios.”
For more information visit Amgen.com.
1. FDA Approves Amgen’s RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab). [press release] Thousand Oaks, CA: Amgen; December 17, 2020.
2. ClinicalTrials.gov. Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (JASMINE). NCT02747043. https://www.clinicaltrials.gov/ct2/show/NCT02747043 Accessed December 18, 2020.