Sandoz, the global leader in affordable medicines, today announced that TYRUKO® (natalizumab-sztn) is available to patients in the US. Developed by Polpharma Biologics, TYRUKO® is the first and only US Food and Drug Administration (FDA) approved natalizumab biosimilar for the treatment of relapsing forms of multiple sclerosis (MS).
Keren Haruvi, President Sandoz North America, said: “As the only biosimilar available to treat multiple sclerosis in the US, TYRUKO® has an important opportunity to help people with MS navigate this disease in a way that is more cost effective. We are proud to be expanding the reach of natalizumab, which underscores our commitment to our Purpose of pioneering access for patients.”
TYRUKO® is approved by the FDA as monotherapy to treat all indications covered by reference medicine Tysabri®* (natalizumab), including relapsing forms of MS and Crohn’s disease in adults.
Leslie Ritter, Vice President of Healthcare Access for the National MS Society, said: “For people living with multiple sclerosis, cost and access to care remain significant barriers. The availability of a biosimilar is an important step forward in making medications more affordable.”
TYRUKO® is available through a Risk Evaluation and Mitigation Strategy (REMS) program designed to inform prescribers, infusion site healthcare providers and patients about the risk of progressive multifocal leukoencephalopathy (PML) associated with natalizumab, including increased risk of PML with the presence of anti-JCV antibodies, longer treatment duration and prior immunosuppressant use1. 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.
Sandoz entered into a global commercialization agreement for biosimilar natalizumab in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for the development of the medicine, manufacturing and supply of the drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets2. In addition to the US, TYRUKO® is now available in 14 European countries.
Sandoz has partnered with Labcorp, a global leader of innovative and comprehensive laboratory services, to develop and validate a laboratory-developed test (LDT) for detecting the presence of anti-JCV antibodies. Labcorp will offer the TYRUKO® JCV Testing Program at no cost to eligible patients, with Sandoz covering the cost of the test.
Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 11 marketed biosimilars and a further 27 assets in various stages of development. The launch of TYRUKO® in the US builds on the company’s established leadership in biosimilars, dating back to the introduction of the first biosimilar in Europe in 2006 and in the US in 2015.
TYRUKO® is expected to be a key contributor to the Sandoz growth strategy. The launch of TYRUKO® builds on the broad Sandoz footprint in neurology in the US. Sandoz has several biosimilars in various stages of development across in-house and partnered programs. TYRUKO® is part of these programs and fits into our ambition to be #1 in biosimilars in the US and a leader in the treatment of MS globally.
