Sandoz BLA: FDA Grants for Proposed Biosimilar Adalimumab


Sandoz, a Novartis division and the global leader in biosimilar medicines, declared that the US Food and Drug Administration (FDA) has granted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.

Mark Levick, global head of development, biopharmaceuticals, Sandoz said, “When patients are treating with a chronic disease, it is imperative they have access to important medication that will enable best to deal with their health”.

“The FDA’s acceptance of the regulatory submission for our biosimilar adalimumab brings us one bit closer to offering a portfolio of options to the huge number of patients in the US who suffer from an inflammatory disease.”

Indications and Usage of Adalimumab:

It is used for the treatment of the number of inflammatory diseases including rheumatoid joint pain, plaque psoriasis, Crohn’s disease and ulcerative colitis.

Rheumatoid arthritis alone affects approximately 1.5 million Americans with 200,000 new cases diagnosed every year. Women are disproportionately (3:1) affected by the disease.

Package information:

The comprehensive information package submitted to the FDA, which contains analytical, preclinical and clinical information, is expected to show 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 and phase III confirmatory safety and efficacy study. Pharmacokinetic study led in healthy volunteers and phase III confirmatory safety and efficacy study led in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS).

Sandoz in Other countries:

Sandoz is focused on increasing patient access to high-quality biosimilars. As the global leader in biosimilars, Sandoz has five biosimilars promoted in different countries around the world, and also a main worldwide pipeline.

Sandoz is very much positioned to continue leading the biosimilars industry based on our experience and capabilities being developed, manufacturing and commercialization.

As a division of Novartis, the first global healthcare company to set up a leading position in both innovative and off-patent medicines, we advantage strongly from this unique combination of experience and expertise in a wide range of market environments.


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