- TYRUKO® approved for all indications of reference medicine Tysabri®*
- Proven to be clinically equivalent to reference product in terms of efficacy and safety
- Expected to be biosimilar growth driver for company
Basel, November 17, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), 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 adults1.
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.
*Tysabri® is a registered trademark of Biogen Idec.
ABOUT TYRUKO® (natalizumab-sztn)
TYRUKO® has been developed to match the reference medicine, an established, highly effective anti-α4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis (MS)1. TYRUKO® is indicated in the US as a monotherapy 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 adults1. It is the first and only FDA-approved natalizumab biosimilar for relapsing forms of MS.
INDICATIONS
Multiple Sclerosis (MS)
TYRUKO® is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML). Therefore, natalizumab is only available through dedicated Risk Evaluation and Mitigation Strategy (REMS) programs. When initiating and continuing treatment with TYRUKO®, physicians should consider whether the expected benefit of TYRUKO® is sufficient to offset this risk.
Crohn’s Disease (CD)
TYRUKO® is indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. TYRUKO® should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α.
SELECT IMPORTANT SAFETY INFORMATION
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WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
See full prescribing information for complete boxed warning.
- Natalizumab products increase the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability.
- Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO®.
- Monitor patients and withhold TYRUKO® immediately at the first sign or symptom suggestive of PML.
- Because of the risk of PML, TYRUKO® is available only through a restricted distribution program called the TYRUKO® REMS Program.
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CONTRAINDICATIONS: Patients who have or have had PML. Patients who have had a hypersensitivity reaction to natalizumab products.
WARNINGS AND PRECAUTIONS: Herpes infections: Life-threatening and fatal cases have occurred with herpes encephalitis and meningitis infections. Blindness has occurred in patients developing acute retinal necrosis. Discontinue TYRUKO® if these infections occur and treat appropriately. Hepatotoxicity: Significant liver injury, including liver failure requiring transplant, has occurred. Discontinue TYRUKO® in patients with evidence of liver injury. Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have occurred. Permanently discontinue TYRUKO® if such a reaction occurs. Immunosuppression/Infections: Natalizumab products may increase the risk for certain infections. Monitor patients for development of infections due to increased risk with use of TYRUKO®. Thrombocytopenia: Natalizumab products may cause thrombocytopenia. Monitor patients for bleeding abnormalities. Discontinue TYRUKO® in patients with thrombocytopenia.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥10%) with natalizumab in the MS studies were headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea NOS, and rash. The most common adverse reactions (incidence ≥10%) in the CD studies were headache, fatigue, upper respiratory tract infections, and nausea.
USE IN SPECIFIC POPULATIONS: Pregnancy: Can cause fetal harm.
This is not the complete list of all safety information for TYRUKO®. Please click to see full Prescribing Information for TYRUKO®.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
1 TYRUKO®. Prescribing Information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761322s002lbl.pdf [Last Accessed: November 2025]
2 Novartis. Sandoz announces global deal to commercialize proposed biosimilar natalizumab, a key multiple sclerosis medicine. Available at: https://www.novartis.com/news/media-releases/sandoz-announces-global-deal-commercialize-proposed-biosimilar-natalizumab-key-multiple-sclerosis-medicine [Last Accessed: November 2025]
3 National MS Society. MS Prevalence. Available at: https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence#:~:text=Prevalence%20of%20MS,people%20at%20a%20given%20time. [Last Accessed: November 2025]
4 MS Society. Relapsing remitting MS (RRMS). Available at: https://www.mssociety.org.uk/about-ms/types-of-ms/relapsing-remitting-ms#:~:text=In%20relapsing%20remitting%20MS%20(RRMS,and%20slow%20down%20your%20MS. [Last Accessed: November 2025]
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.
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