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Amgen’s Humira biosimilar succeeds in Phase III arthritis study

Published on 16/11/15 at 09:33am

Amgen says its Humira (adalimumab) biosimilar candidate ABP 501 proved its clinical equivalence to Abbvie’s blockbuster drug in a head-to-head Phase III study in patients with moderate-to-severe rheumatoid arthritis.

The results were presented at the 2015 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Francisco.

The study to test the safety, efficacy and immunogenicity of ABP 501 met its primary endpoint, which was achievement of ACR20 (20 percent or greater improvement in ACR assessment) at week 24. By this time, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria.

"Demonstrating biosimilarity is scientifically complex, but Amgen's 35 years of proven biologic R&D experience is facilitating the advancement of exciting programs like ABP 501," says Sean Harper, executive vice president of Research and Development at Amgen. "Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide."

ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

Adalimumab is sold under the brand name Humira by Abbvie, and is currently the world’s bestselling drug. It faces competition not only from Amgen’s biosimilar, but also Eli Lilly’s baricitinib, which outperformed it in a recent late-stage trial.

Joel Levy

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