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FDA Accepts Application for New Humira Biosimilar
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Sandoz announced that the FDA has accepted a biologics license application for a proposed biosimilar of the anti-inflammatory drug adalimumab, known commercially as Humira.
Adalimumab is an anti-TNF medicine used to treat several immunological diseases, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis and plaque psoriasis.
“When patients are dealing with a chronic disease, it is imperative that they have access to important medication that will help best manage their health,” Mark Levick, the global head of development, Biopharmaceuticals at Sandoz said in the 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.”
Sandoz submitted a data package that included analytical, preclinical and clinical data to the FDA, which they expect to demonstrate that the proposed biosimilar matches the reference biologic in terms of safety, efficacy and quality. The company also submitted a pharmacokinetic study of healthy volunteers and a phase 3 confirmatory safety and efficacy study of patients with moderate to severe plaque-type psoriasis to the FDA, according to the press release. – by Alex Young
Disclosures: Levick is employed by Sandoz.