FDA Adds Indications for Rheumatoid Arthritis to Bio-Ribni Rituximab

Adult patients with rheumatoid arthritis (RA) have been added to the list of indications for biosimilars to rituximab Ryabne (rituximab-ARX) thanks to a comparative clinical study.

Rheumatoid arthritis, a chronic inflammatory and autoimmune disorder, causes the immune system to mistakenly attack the body’s tissues and joints. Photo: shutterstock

This indication is for adults with moderate to highly active disease who have had an inadequate response to one or more TNF inhibitors.

US Food and Drug Administration approval (Food and Drug Administration), happening around Results From study A randomized, double-blind, clinical trial compared to the reference anti-CD20 antibody reference product, Rituxan, biosimilars manufacturer, Amgen.

saying study One clinical trial that tested Riabni versus Rituxan included 311 patients with moderate to severe rheumatoid arthritis who received Riabni and Rituxan manufactured in the United States and Rituxan manufactured in the European Union. Patients who received the US-made drug Rituxan switched to Ryapni for their second dose of rituximab, while patients in other groups remained on the same treatment.

The primary efficacy endpoint for the clinical trial, the change in disease activity score in 28 joints with C-reactive protein from baseline to week 24, was within the pre-established equivalence margin for clinical efficacy between Riabni and Rituxan. The two products also have similar pharmacokinetic and immunomodulatory safety features, according to pharmaceutical company Amgen.

Currently, Riabni and Ruxience (rituximab-pvvr) are the only biosimilars to rituximab approved in the United States. Ruxience is approved for the same indications. Rituxan only has orphan drug status protected for indication in adult patients with moderate to severe pemphigus vulgaris.

This drug was previously approved in December 2020 for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

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