The U.S. Food and Drug Administration has agreed to review Sandoz's application for a biosimilar to AbbVie's bowel disease therapy Humira (adalimumab). "When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health," Mark Levick, Sandoz's global head of development for biopharmaceuticals, said in a press release. "The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the U.S. who suffer from an inflammatory disease," he said. A biosimilar is a biological medical product with the same qualities of an already licensed treatment. It is usually much cheaper than the original. Sandoz has supported its application with preclinical-trial and trial data showing that GP2017 matches Humira's quality, safety, and effectiveness. It includes results from a study of healthy volunteers and from the Phase 3 ADACCESS trial (NCT02016105) of patients with moderate-to-severe chronic plaque-type psoriasis. The studies compared the effectiveness of 40 mg of injected GP2017 and Humira every other week in 318 healthy volunteers and 465 patients with plaque-type psoriasis. Researchers discussed the results at the 2017 American College of Rheumatology Annual Meeting in presentations titled: “Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab,” and “Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects