ABP 501 biosimilar met endpoints in Phase III study comparison with Humira for Psoriasis - Amgen

Amgen announced its Phase III study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe Plaque Psoriasis met its primary endpoint. The primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment.

At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab. This is the first of two Phase III studies intended to form the basis for global regulatory submissions for ABP 501. ABP 501 is being developed as a biosimilar to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis.