FDA approves Tyruko, first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis – Sandoz
Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has 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 (MS).
Keren Haruvi, President North America, Sandoz Inc., said: “Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”
Tyruko is approved as a monotherapy to treat all indications covered by reference medicine Tysabri (natalizumab) for relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, as well as Crohn’s disease in adults.
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 (REMS). Tyruko has the same intravenous (IV) 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.