The US Food and Drug Administration (FDA) has agreed to review the biologics licence application (BLA) submitted by Sandoz, division of Novartis, for proposed biosimilar adalimumab to reference medicine Humira.
Adalimumab is an anti-tumour necrosis factor (TNF) medicine indicated to treat various inflammatory disorders such as rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.
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Sandoz provided the FDA with analytical, preclinical and clinical data, which is expected to demonstrate that the safety, efficacy and quality of adalimumab are similar to those of the reference biologic.
The BLA includes findings from the proposed biosimilar’s pharmacokinetic study performed in healthy participants and the Phase III ADACCESS confirmatory safety and efficacy trial in patients suffering from moderate-to-severe chronic plaque-type psoriasis.
Sandoz Biopharmaceuticals Development global head Mark Levick said: “When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health.
“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.”
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By GlobalDataIn addition to adalimumab, the biosimilar pipeline of Sandoz includes etanercept, pegfilgrastim, rituximab and infliximab.
Etanercept and infliximab are being developed for the treatment of autoimmune disorders such as psoriasis and rheumatoid arthritis, while pegfilgrastim and rituximab have potential for treatment of oncology.
