- Biosimilar Tyruko approved for all indications of reference medicine, with same dosing and administration schedule
- Sandoz continues to expand access to much-needed medications for patients in US, offering another treatment option to help control relapsing forms of multiple sclerosis
- US FDA approval based on robust Phase I and Phase III clinical studies; each met primary endpoints and showed Tyruko provides same risks and benefits in terms of efficacy, safety and immunogenicity as reference medicine
Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).
Keren Haruvi, President North America, Sandoz Inc., said: “Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”
Tyruko is approved as a monotherapy to treat all indications covered by reference medicine Tysabri* (natalizumab) 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 adults.1
Bari Talente, the National MS Society’s Executive Vice President for Advocacy and Healthcare Access, said: “Access to affordable, high-quality healthcare is essential for people with multiple sclerosis to live their best lives. The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone. Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs.”
The FDA granted approval based on a robust data package, including analytical, functional and clinical data. The approval is accompanied by labeling with safety warnings and a Risk Evaluation and Mitigation Strategy (REMS).
Tyruko has the same intravenous (IV) dosage form, route of administration, dosing regimen and presentation as the reference medicine. Sandoz is dedicated to all aspects of patient safety with Tyruko, which, upon launch, will be available through the Sandoz REMS program.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect daily life.2 Most people with MS experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.3
Sandoz entered into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply of the active substance in Tyruko. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets. Sandoz is committed to bringing this important medicine to US patients as soon as possible.
About Tyruko (natalizumab-sztn)
Tyruko has been developed to be highly similar to the reference medicine, an established, highly effective anti-α4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis (MS). 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 adults.1 It is the first and only FDA-approved biosimilar for relapsing forms of MS.
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.
1. Tyruko. Prescribing Information. Available at: Prescribing Information
2. MS International Federation. What is MS? October 2021. Accessed May 17, 2022. https://www.msif.org/about-ms/what-is-ms/
3. Mayo Clinic. About Multiple Sclerosis. 2022. Accessed July 7, 2023. Available from: https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269.
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our vision is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines covers major therapeutic areas.