The US Food and Drug Administration (FDA) has approved Sandoz’s 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.
Bari Talente, the National MS Society’s Executive Vice President for Advocacy and Healthcare Access, said: “Access to affordable, high-quality healthcare is essential for people with multiple sclerosis to live their best lives. The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone.
“Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs.”
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.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect daily life. Most people with MS experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.
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.