FDA approves Amgen’s rituximab biosimilar for treatment of moderate-to-severe RA
The FDA has approved rituximab-arrx, in combination with methotrexate, in adult patients with moderate or severely active rheumatoid arthritis who have had inadequate responses to one or more TNF agonist therapies.
Rituximab-arrx (Riabni, Amgen), a biosimilar to rituximab (Rituxan, Genentech) was previously approved for indications including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
“The approval of Riabni is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option,” Murdo Gordon, executive vice president of global commercial operations at Amgen, said in a press release. “Our fully integrated portfolio of innovative and biosimilar medicines for inflammatory diseases reinforces our commitment to providing patients with high-quality and affordable treatment options that deliver substantial value to our healthcare system.”
Rituximab-arrx was compared with rituximab in a randomized, double-blind, comparative study investigating the efficacy and safety of the drug. Researchers also evaluated the drug’s pharmacokinetics and immunogenicity. In all, 311 patients with RA were randomized to receive either rituximab-arrx, rituximab-US or rituximab-EU. The group receiving rituximab-US transitioned to begin receiving rituximab-arrx during period 2 of the study.
The primary endpoint of the study was the change in DAS28 using C-reactive protein from baseline at week 24. The primary endpoint was within the predefined equivalence margin. Safety, pharmacokinetics and immunogenicity were all similar to the reference product as well, the release said.