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Amgen's Infliximab Biosimilar Demonstrates Top-Line Results in Phase 3 Trial
Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).
Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA).
The randomized double-blind study enrolled 558 and randomized (1:1) 558 patients with RA to receive either ABP 710 or reference infliximab at a dose of 3 mg/kg infused on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The ABP 710 arm, as well as the reference infliximab arm, were equally comprised of 279 patients.
The primary end point of the study was achieving 20% or greater improvement as defined by the American College of Rheumatology criteria (ACR20) at week 22. Secondary endpoints included achieving ACR50, ACR70, and disease activity score 28-joint count C reactive protein (DAS28-CRP).
Researchers confirmed the noninferiority of ABP 710 compared with infliximab, but “could not rule out superiority based on its primary efficacy endpoint,” according to the news release. Notably, the DAS28-CRP difference in mean change from the baseline was close to 0, at —0.01 (95% CI, –0.20 to 0.17). In addition, the safety profile and immunogenicity were comparable between ABP 710 and the originator.
“We believe this study confirms no clinically meaningful differences between ABP 710 and [reference] infliximab. Biosimilars are approved based on the analytical, nonclinical, and clinical data, and we believe that the totality of the evidence we’ve generated supports ABP 710 as highly similar to the reference product,” said Sean Harper, MD, executive vice president of research and development at Amgen in a statement.
Amgen is also working on the development of a number of other biosimilar products, including ABP 494, biosimilar cetuximab; ABP 798, biosimilar rituximab; ABP 959, biosimilar eculizumab, and Kanjinti, a trastuzumab biosimilar that was authorized for marketing in Europe in May 2018, 1 day after it was announced that the FDA had issued a Complete Response Letter for the same product.
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