Sandoz, a Novartis division and the global leader in biosimilar medicines, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira®*.
"When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health." said Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz. "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 (ADACCESS)
