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FDA Approval

FDA Approves Rituximab Biosimilar for NHL and CLL

December 21, 2020

On December 17, 2020, the FDA granted approval to rituximab-arrx (Riabni, Amgen), biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA; Wegener's Granulomatosis), and microscopic polyangiitis (MPA).

The similarity of rituximab-arrx to the reference drug was demonstrated in a randomized, double-blind, comparative clinical study. The study evaluated the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of rituximab-arrx compared to the reference drug in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden.

A total of 256 patients were enrolled in the study and randomized 1:1 to receive 375 mg/m2 intravenous infusion of rituximab-arrx or the reference drug once weekly for 4 weeks followed by dosing at weeks 12 and 20.

The primary end point of the study was overall response rate (ORR) by week 28.

Rituximab-arrx was proven to be highly similar to the reference drug based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness.

The US wholesale acquisition cost of rituximab-arrx will be 23.7% lower than the reference drug. At launch, rituximab-arrx will be priced 16.7% below the current average selling price for the reference drug.

Rituximab-arrx will be made available in the US in January of 2021.—Janelle Bradley

Source: Cision PR Newswire. FDA Approves Amgen's RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan® (rituximab), December 17, 2020. Accessed December 21, 2020.

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