Sandoz has launched TYRUKO® (natalizumab-sztn) in the United States, marking the arrival of the first and only FDA-approved biosimilar to natalizumab for relapsing forms of multiple sclerosis (MS). Developed by Polpharma Biologics, the therapy offers a more affordable treatment option for individuals living with MS and expands access to a critical biologic previously limited to its reference medicine, Tysabri®.
As the only MS biosimilar available in the country, TYRUKO® represents a meaningful opportunity to reduce treatment costs and broaden patient access. It is approved as a monotherapy for all adult indications covered by the reference product, including relapsing MS and Crohn’s disease. Its introduction is especially significant given the ongoing challenges patients face regarding affordability and consistent access to long-term MS therapy.
The availability of TYRUKO® is supported by a Risk Evaluation and Mitigation Strategy (REMS) program designed to educate healthcare providers and patients about the risk of progressive multifocal leukoencephalopathy (PML). The program outlines key risk factors, discourages combined use with immunosuppressive therapies, and emphasizes early detection and prompt intervention if PML is suspected.
Sandoz and Polpharma Biologics partnered in 2019 under a global commercialization agreement, through which Polpharma Biologics oversees development and production while Sandoz manages worldwide distribution. TYRUKO® is now accessible in the US and 14 European countries, reflecting a growing global footprint.
To further support safe therapy management, Sandoz has collaborated with Labcorp to develop a validated test for detecting anti-JCV antibodies—an important factor in PML risk assessment. This test will be provided at no cost to eligible patients through the TYRUKO® JCV Testing Program.
With an expanding biosimilar portfolio and a long-standing leadership position in the category, Sandoz expects TYRUKO® to be a key driver of its growth strategy. The launch enhances its US neurology presence and aligns with its broader ambition to lead in biosimilars and advance global access to life-changing biologic therapies.
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