Amgen announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting the company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).
"With our heritage in both rheumatology and dermatology, we are committed to providing physicians and patients a variety of biologic options, which are critical for the long-term management of these serious diseases," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee."
The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two phase 3 comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.
The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-a monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (US) and adalimumab (EU).
