FDA Accepts Application for Novartis' Biosimilar to Humira

Sandoz, the generics division within Novartis, has 5 biosimilars currently being marketed worldwide.

This morning, the company announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the proposed biosimilar adalimumab to the reference medicine, Humira, developed by AbbVie, Inc.

Previously, the FDA has approved other biosimilars for Humira, including Cytelzo, developed by Boehringer Ingelheim, and Amgen’s Amjevita.

Adalimumab binds to tumor necrosis factor-alpha (TNFa), a protein involved in the inflammatory response of several autoimmune diseases.

Today’s news is based on results from clinical studies submitted to the FDA, including a pharmacokinetic study in healthy volunteers and a Phase 3 confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis. The drug has already proven its effectiveness in other patient populations, including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis.

“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.”

In May, the European Medicines Agency accepted for regulatory review their Marketing Authorization Applications for the biosimilar to treat immunological diseases.

For more breaking news from the FDA, follow Rare Disease Report on Facebook and Twitter.