Sandoz Expands US Biosimilar Portfolio with TYRUKO for Relapsing Multiple Sclerosis and Crohn’s Disease

Sandoz Expands US Biosimilar Portfolio with TYRUKO for Relapsing Multiple Sclerosis and Crohn’s Disease

(IN BRIEF) Sandoz has announced the US availability of TYRUKO® (natalizumab-sztn), the first FDA-approved biosimilar to Tysabri® for treating relapsing forms of multiple sclerosis and Crohn’s disease. Developed by Polpharma Biologics, TYRUKO® is clinically equivalent to its reference product and intended to increase access to high-cost biologics. Under a global commercialization agreement, Polpharma manages production while Sandoz handles marketing and distribution. TYRUKO® is available through a REMS program to manage the risk of progressive multifocal leukoencephalopathy (PML), and is supported by a no-cost JCV antibody testing program through Labcorp. The launch adds to Sandoz’s expanding biosimilar portfolio, reinforcing its strategy to be a leading provider of affordable biologic treatments, especially in neurology. TYRUKO® is now available in the US and 14 European countries and is projected to drive significant growth for the company’s biosimilar division.

(PRESS RELEASE) BASEL, 17-Nov-2025 — /EuropaWire/ — Sandoz (SIX:SDZ/OTCQX:SDZNY), a leading global provider of affordable medicines, announced today that TYRUKO® (natalizumab-sztn), the first and only FDA-approved biosimilar to Tysabri® for the treatment of relapsing forms of multiple sclerosis (MS), is now available in the United States. Developed in partnership with Polpharma Biologics, TYRUKO® offers a clinically equivalent, but potentially more cost-effective option for eligible patients living with MS and Crohn’s disease.

The approval represents a key milestone not only for Sandoz’s biosimilar portfolio but also for patients who face significant treatment costs for chronic autoimmune conditions. “As the only biosimilar available to treat MS in the US, TYRUKO® holds great promise for making treatment more accessible,” said Keren Haruvi, President Sandoz North America. “This launch reinforces our commitment to pioneering access and improving affordability for patients.”

TYRUKO® carries the same indications as the reference drug Tysabri®, covering all relapsing forms of MS and moderately to severely active Crohn’s disease in adults. The product is distributed under a Risk Evaluation and Mitigation Strategy (REMS) program to mitigate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with natalizumab. A key part of Sandoz’s launch support includes partnering with Labcorp to provide a no-cost JCV antibody test to eligible patients, aiding prescribers in monitoring PML risk factors early and effectively.

Since signing a global commercialization agreement in 2019, Sandoz and Polpharma Biologics have been working toward the widespread availability of TNF inhibitors like natalizumab. Polpharma Biologics retained responsibility for development and manufacturing, while Sandoz manages commercial distribution under an exclusive license covering all markets.

TYRUKO® is already available to patients in 14 European countries, and today’s US launch forms part of the company’s wider strategy to expand access to high-quality biosimilars and consolidate its leadership in neurology. The biosimilar represents an important growth driver for Sandoz, which currently has 11 marketed biosimilars and an additional 27 assets in development across its global pipeline. With strong momentum and a commitment to innovation and affordability, Sandoz aims to be the leading biosimilar provider in the US and a global leader in MS care.

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

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.

CONTACTS

SOURCE: Sandoz