Novartis division Sandoz has had its Biologics License Application for proposed Humira biosimilar adalimumab accepted by the US FDA.
Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz, said: “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 US who suffer from an inflammatory disease.”
Adalimumab is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.
Rheumatoid arthritis alone affects approximately 1.5 million Americans with 200,000 new cases diagnosed each year. Women are disproportionately (3:1) affected by the disease.
The comprehensive data package submitted to the FDA, which comprises analytical, preclinical and clinical data, is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference biologic in terms of safety, efficacy and quality.
Clinical studies submitted to the FDA include a pharmacokinetic study in healthy volunteers and a Phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis.