ABP 501 biosimilar Phase III study equivalent to Humira in RA- Amgen
Amgen has announced a Phase III study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe Rheumatoid Arthritis met its primary and key secondary endpoints. The primary endpoint compared the ACR20 measurements (20 percent or greater improvement in ACR assessment) at week 24. The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence. Safety and immunogenicity of ABP 501 were comparable to adalimumab. Key secondary endpoints included ACR50, ACR70 and DAS 28-CRP.
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-? monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.
Comment: The patents to Humira expire in the EU in 2016 and in the US in 2018.
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