Sandoz, a global leader in generic and biosimilar medicines, announced that the US Food and Drug Administration (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.
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 labelling with safety warnings and a Risk Evaluation and Mitigation Strategy (REMS).
