FDA Approves Amgen’s Riabni™ (rituximab-arrx) for Moderate to Severe Rheumatoid Arthritis

News on June 15, 2022 /BioValleyBIOON/ -- Amgen recently announced that the U.S. Food and DrugManagementBureau (FDA) has been approvedRiabni (rituximab-arrx): In combination with methotrexate, used to treat moderate to severe active disease in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonists.Rheumatoid Arthritis(RA) adult patients.

Riabni is a biosimilar of Roche's blockbuster biologic Rituxan (Chinese trade name: MabThera, generic name: rituximab).. In the United States, Riabni has previously been approved for the treatment of: non-HodgkinLymphoma(NHL), Chronic LymphocyticLeukemia(CLL), Granuloma with Poly-Blood VesselPolyarteritis Nodosa (GPA), Microscopic Polyangiitis (MPA) in adult patients.

Rituxan is a therapeutic monoclonal antibody targeting CD20., approved in multiple countries worldwide, for the treatment of: (1) various oncology indications, including NHL, CLL; (2) various autoimmuneImmunitySexually transmitted disease indications, including rheumatoid arthritis (RA), GPA, MPA, and pemphigus vulgaris (PV).

Currently,Amgen has 11 biosimilars in its pipeline, five of which have been approved in the United States and three in the European Union.Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen, stated: "The approval of Riabni represents an important advancement for adults suffering from moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, as they now have access to a clinically proven and affordable treatment option. Our comprehensive and integrated portfolio of innovative medicines and biosimilars for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable therapeutic choices, delivering significant value to our healthcare system."

Riabni is a CD20-directed cytolytic monoclonal antibody with the same amino acid sequence as Rituxan. Based on all evidence, including comparative analyses, non-clinical, and clinical data, Riabni has been demonstrated to be highly similar to Rituxan, with no clinically meaningful differences in safety or efficacy.

A randomized, double-blind, comparative clinical study compared the efficacy, safety, pharmacokinetics, and immunogenicity of Riabni with rituximab reference product (RP) in patients with moderate to severe RA. Overall, 311 patients were randomly assigned to receive Riabni, EU-approved rituximab RP (rituximab-EU), or US-approved rituximab RP (rituximab-US).

The rituximab-US group switched to Riabni treatment in the second phase of the study. The primary efficacy endpoint, the change from baseline in DAS28-CRP (Disease Activity Score using 28 joints and C-reactive protein) at week 24, fell within the pre-defined equivalence margin, indicating clinical equivalence between Riabni and rituximab RP. The safety, pharmacokinetics, and immunogenicity of Riabni were similar to those of rituximab RP.(Bioon.com)

Source of the Original Text:FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS