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Pharmacokinetic, pharmacodynamic equivalence demonstrated between rituximab, biosimilar in RA
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Among patients with rheumatoid arthritis, pharmacokinetic and pharmacodynamic equivalence was demonstrated between rituximab — as both the European and U.S. versions — and GP2013, a biosimilar to rituximab, according to a recently published analysis.
“The current study is part of the stepwise demonstration of similarity of the proposed biosimilar GP2013, RTX-EU and RTX-US,” Josef S. Smolen, MD, from the department of rheumatology at the Medical University of Vienna, and colleagues wrote. “The data are in line with previously published RTX data.”
Researchers assessed both the European rituximab (MabThera, Hoffmann-La Roche) and U.S. rituximab (Rituxan, Genentech/Biogen Idec) reference product in comparison with the biosimilar GP2013 (Sandoz) all in combination with methotrexate and folic acid in 312 patients with active RA despite prior tumor necrosis factor therapy. They found the 90% CI of the geometric mean ratio of the area under the curves (AUCs) remained within bioequivalence limits of 80% to 125% for all three comparisons. In the GP2013 vs. RTX-EU comparison, the AUC was 1.106. For the GP2013 vs. RTX-US comparison, the AUC was 1.012. And for the RTX-EU vs. RTX-US comparison, the AUC was 1.093. They also found three-way pharmacodynamic equivalence of B-cell depletion. In addition, efficacy, safety and immunogenicity profiles were similar between groups. – by Will A. Offit
Disclosures: The study was supported by Hexal. Smolen reports receiving investigator fees from Sandoz. Please see the full study for a list of all other authors’ relevant financial disclosures.
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