First completed Phase III Study of adalimumab biosimilar in patients with moderate-to-severe RA

US biotech major Amgen (Nasdaq: AMGN) yesterday presented detailed findings from a head-to-head Phase III study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab, AbbVie's blockbuster drug (NYSE: ABBV) Humira, in patients with moderate-to-severe rheumatoid arthritis.

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

The study met the primary endpoint, which was achievement of ACR20 (20% or greater improvement in ACR assessment) at week 24.  At week 24, 74.6% of patients in the ABP 501 group and 72.4% in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90% CI of 0.954–1.133, which fell within the predefined equivalence margin.