Amgen’s Rheumatoid Arthritis Biosimilar Meets Primary Endpoint

Amgen’s biosimilar candidate ABP 501 met its primary endpoint in patients with moderate-to-severe rheumatoid arthritis in a Phase 3 study measuring the safety, efficacy and immunogenicity of the drug compared with AbbVie’s Humira.

The study’s primary endpoint — measured as 20 percent or greater improvement in the American College of Rheumatology’s assessment at week 24 — was met by 74.6 percent of patients in the ABP 501 group and 72.4 percent in the Humira (adalimumab) group.

The two drugs demonstrated similar results in secondary endpoint measurements, with 49.2 percent of ABP 501 patients achieving a 50 percent or greater improvement (ACR50) compared with 52 percent of Humira patients. Additionally, 26 percent of ABP 501 patients achieved at least 70 percent improvement (ACR70) versus 22.9 percent of Humira patients.

The results were presented Nov. 9 at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in San Francisco, Calif.