medwireNews: The rituximab biosimilar GP2013 is noninferior to its reference product for the treatment of patients with rheumatoid arthritis (RA) and an inadequate response to tumor necrosis factor inhibitor treatment, study results suggest.
GP2013 and rituximab were “similar in terms of efficacy, safety and immunogenicity,” say Tamas Shisha (Sandoz, Holzkirchen, Germany) and study co-authors.
Disease Activity Score at 28 joints based on C-reactive protein (DAS28-CRP) decreased by 2.07 points from baseline to week 24 among 133 study participants randomly assigned to receive GP2013 compared with 2.11 points for the 179 given rituximab, giving a difference within the prespecified noninferiority margin of 0.6 points.
The incidence of treatment-related adverse events, serious adverse events, and infusion-related reactions was comparable in the GP2013 and rituximab groups, as was the rate of binding antidrug antibodies.
And the 90% confidence intervals of the area under the serum concentration–time curve were within the bioequivalence limits of 80% to 125% for all comparisons between GP2013 and its US and European reference products, “demonstrating three-way [pharmacokinetic and pharmacodynamic] bioequivalence,” report the researchers in the Annals of the Rheumatic Diseases.
By Claire Barnard
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