FDA accepts Sandoz’s submition for adalimumad in reference to Humira

Novartises division Sandoz has asked the FDA to review their Biologic License Application for biosimilar adalimumad, related to Humira, for treating rheumatoid arhtritis, plaque psoriasis and other inflammatory diseases. 

US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for the proposed biosimilar, Sandoz said Tuesday.

Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz, said that it is important to offer patients with chronic disease the drug that will help best help them. That’s why, he says, the FDA’s acceptance of the regulatory submission for Sandoz’s biosimilar gets us all closer to have 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.

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