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Sandoz launches Tyruko in U.S. as first and only MS biosimilar
noviembre 20, 2025
Tyruko is available to patients in the U.S., according to Sandoz Developed by Polpharma Biologics, Tyruko is the first and only U.S. Food and Drug Administration approved natalizumab biosimilar for the treatment of relapsing forms of multiple sclerosis.
Tyruko is approved by the FDA as monotherapy to treat all indications covered by reference medicine Tysabri, including relapsing forms of MS.
Tyruko is available through a Risk Evaluation and Mitigation Strategy program. It is designed to inform prescribers, infusion site healthcare providers, and patients about the risk of progressive multifocal leukoencephalopathy linked to natalizumab. This includes increased risk of PML with the presence of anti-JCV antibodies, longer treatment duration, and prior immunosuppressant use. The program warns against concurrent use with antineoplastic, immunosuppressant or immunomodulating agents and, in patients who are immunocompromised, promotes early diagnosis of PML and timely discontinuation of Tyruko in the event of suspected PML.
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