Amgen’s adalimumab biosimilar hits the target of Phase III study

October 13, 2014 10:01 AM

Amgen last week announced its Phase 3 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 3 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-?  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.

“Results from Amgen’s biosimilar Phase 3 plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the Company’s commitment to provide patients with access to high-quality medicines,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to continuing to leverage our experience and expertise in biotechnology to bring biosimilars to patients.”

Amgen has six biosimilar molecules in development and expects to launch the portfolio starting in 2017.

Source: Amgen

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