FDA to Review Humira Biosimilar
Anti-TNF-a monoclonal antibody treats moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.
The FDA recently announced a review of Amgen’s Biologics License Application (BLA) for ABP 501, which is an anti-TNF-a monoclonal antibody biosimilar candidate to adalimumab (Humira).
The FDA Arthritis Advisory Committee will review all analytical, clinical, and pharmacokinetic data from studies using ABP 501. This includes results from a pair of phase 3 comparative safety and efficacy studies used for both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.
The phase 3 studies met their primary endpoints and showed clinical equivalence to Humira. The safety and immunogenicity of ABP 501 was also found to be comparable to Humira.
The submission includes data that supports the transition of Humira patients to ABP 501. For ABP 501, a Biosimilar User Fee Act (BsUFA) target action date was set by the FDA for September 25, 2016.
“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, MD, 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.”