Amgen reporting progress for its biosimilar candidate, ABP 501, which is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. the reference product and the active ingredient in AbbVie’s Humira, 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.

Amgen reported that a Phase III study evaluating the efficacy and safety of ti 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.

Amgen has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019.

Source: Amgen