FDA advisory committee to review biosimilar candidate to Humira

The Arthritis Advisory Committee of the FDA has agreed to review data supporting Amgen’s Biologics License Application for ABP 501, a biosimilar to Humira, according to a press release from Amgen.

The committee is scheduled to review data from studies, including two phase 3 comparative efficacy and safety studies of ABP 501, a biosimilar to Humira (adalimumab, AbbVie), an anti-tumor necrosis factor-alpha (TNF-a) monoclonal antibody. The studies looked at the efficacy and safety of ABP 501for treating moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, according to the release.

Primary endpoints showing clinical equivalence to adalimumab were met, and safety and immunogenicity were also comparable to adalimumab, according to the release. There were data supporting the transition of patients on adalimumab to ABP 501 included in Amgen’s submission.

“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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, stated in the release. “We look forward to the comprehensive data package for ABP 501 with the members of the committee.”

ABP 501’s active ingredient is an anti-TNF-a monoclonal antibody that has the same amino acid sequence as adalimumab. The biosimilar candidate has the same pharmaceutical dosage form and strength as adalimumab, according to the release.

A Biosimilar User Fee Act target action date of Sept. 25, 2016, has been set by the FDA for ABP 501.

Reference: www.amgen.com