FDA approves biosimilar Tyruko for relapsing forms of MS

August 25, 2023
Sandoz announced the U.S. Food and Drug Administration approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.

Tyruko is approved as a monotherapy to treat all indications covered by reference medicine Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease.

The FDA granted approval based on a robust data package, including analytical, functional, and clinical data. The approval is accompanied by labeling with safety warnings and a risk evaluation and mitigation strategy.

According to MS Focus senior medical advisor Dr. Ben Thrower, “Having more options for managing MS is always a good thing. The past few years have seen some name brand MS disease-modifying therapies go off patent and generics become available. Monoclonal antibodies such as Tysabri, Ocrevus, Kesimpta, Briumvi, and Lemtrada fall into a class of drugs called biologics. When these drugs go off-patent and a competitor is developed, those therapies are called biosimilars. We now have a biosimilar to Tysabri on the close horizon. A head-to-head study of name brand Tysabri compared to the biosimilar natalizumab showed equal effectiveness. 

“An unresolved issue is how JC virus antibody testing will be done with the new biosimilar version of natalizumab. JC virus antibody testing is a crucial part of selecting appropriate individuals for natalizumab and allowing them to stay on the therapy safely. At this time, the plan is for the new biosimilar natalizumab to also have a new JC virus antibody assay. This will need to be carefully looked at. Our current experience with minimizing the risk of PML with natalizumab is based on the existing JC virus assay and the long-term data that goes with it.” 

Tyruko has the same intravenous dosage form, route of administration, dosing regimen, and presentation as the reference medicine. Sandoz is dedicated to all aspects of patient safety with Tyruko, which, upon launch, will be available through the Sandoz REMS program.

Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing, and supply of the active substance in Tyruko. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets. Sandoz is committed to bringing this important medicine to US patients as soon as possible.

Tyruko has been developed to be highly similar to the reference medicine, an established, highly effective anti-α4 integrin monoclonal antibody disease-modifying treatment in relapsing forms of MS. Tyruko is indicated in the U.S. as a monotherapy for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease. It is the first and only FDA-approved biosimilar for relapsing forms of MS.

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