Sandoz Group AG has launched TYRUKO (natalizumab-sztn) in the United States, marking a significant milestone as the first and only FDA-approved natalizumab biosimilar for multiple sclerosis treatment. Developed by Polpharma Biologics, this biosimilar offers patients with relapsing forms of MS a more cost-effective alternative to the reference medicine Tysabri.
Clinical Approval and Indications
TYRUKO has been approved by the FDA as monotherapy for all indications covered by reference medicine Tysabri (natalizumab), including relapsing forms of multiple sclerosis and Crohn's disease in adults. The biosimilar is indicated for the treatment of relapsing forms of MS, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease.
The product has been proven to be clinically equivalent to the reference product in terms of efficacy and safety, representing an established, highly effective anti-α4 integrin monoclonal antibody disease modifying treatment.
Safety Profile and Risk Management
Due to the risk of progressive multifocal leukoencephalopathy (PML), TYRUKO is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. This program is designed to inform prescribers, infusion site healthcare providers, and patients about PML risks associated with natalizumab, including increased risk 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 promotes early diagnosis of PML and timely discontinuation of TYRUKO in the event of suspected PML, particularly in immunocompromised patients.
Partnership and Testing Program
Sandoz has partnered with Labcorp, a global leader in laboratory services, to develop and validate a laboratory-developed test (LDT) for detecting anti-JCV antibodies. Labcorp will offer the TYRUKO JCV Testing Program at no cost to eligible patients, with Sandoz covering the test costs.
Market Impact and Accessibility
Keren Haruvi, President Sandoz North America, stated: "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."
Leslie Ritter, Vice President of Healthcare Access for the National MS Society, emphasized the significance of this launch: "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."
Global Commercialization Strategy
Sandoz entered into a global commercialization agreement for biosimilar natalizumab in 2019. Under this agreement, Polpharma Biologics maintains responsibility for medicine development, manufacturing, and drug substance supply, while Sandoz holds exclusive global licensing rights for commercialization and distribution across all markets.
In addition to the US launch, TYRUKO is currently available in 14 European countries, demonstrating the global reach of this therapeutic option.
Safety Information and Adverse Reactions
The most common adverse reactions (incidence ≥10%) with natalizumab in MS studies include headache, fatigue, arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash.
Additional warnings and precautions include risks of herpes infections, hepatotoxicity, hypersensitivity reactions, immunosuppression/infections, and thrombocytopenia. The product is contraindicated in patients who have or have had PML and those with hypersensitivity reactions to natalizumab products.
Strategic Significance for Sandoz
TYRUKO is expected to be a key contributor to Sandoz's growth strategy and 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. The launch strengthens Sandoz's broad footprint in neurology in the US and supports the company's ambition to be the leading biosimilar provider in the US market.
Sandoz maintains a leading global portfolio comprising 11 marketed biosimilars and 27 additional assets in various stages of development, demonstrating its commitment to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably.
