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.”
They also talked about them at the 2017 American Academy of Dermatology Annual Meeting in a presentation titled “A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.”
The European Medicines Agency is reviewing an application for GP2017 as well as Sandoz’s application for GP1111, a biosimilar for another bowel disease drug, Janssen’s Remicade (infliximab). Sandoz acquired the European Union rights to GP1111 from Pfizer.
The medicine agency’s “acceptance of our regulatory submission for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing immunology pipeline,” Levick said in a press release.