Written By: Pharmacally Medical News Desk
Sandoz has officially launched Tyruko® (natalizumab-sztn) in the United States as of November 2025, marking a major milestone as the first biosimilar to Biogen’s Tysabri® (natalizumab). This launch follows the FDA approval of Tyruko® in August 2023 and represents a significant advancement in providing a more accessible and cost-effective treatment option for patients with relapsing forms of multiple sclerosis (MS) and related conditions.
The U.S. launch had faced regulatory delays due to safety testing requirements, particularly involving the John Cunningham virus (JCV) assay, which is critical for managing risks associated with natalizumab therapies. With these safety protocols now addressed, Tyruko® is commercially available, providing healthcare providers and patients an effective biosimilar option that matches the reference medicine in efficacy, safety, and administration.
Tysabri has been a cornerstone treatment for MS, but its high cost has limited access for many. The introduction of Tyruko® is expected to increase treatment accessibility by adopting competitive pricing and expanding options for MS management.
Sandoz, part of the Novartis Group, co-developed Tyruko® with Polpharma Biologics, which manufactures the biosimilar. The launch reinforces Sandoz’s leadership in the biosimilars market, emphasizing their commitment to broadening patient access to biologic therapies.
This development is welcomed by the MS community and healthcare professional, emphasizing safety through ongoing risk management strategies while enhancing patient access to vital therapies. Tyruko® now offers a promising new avenue for patients suffering from relapsing MS and other Tysabri-approved conditions in the US.
The commercial availability of Tyruko® signals a new competitive era in MS treatment, ultimately aiming to make lifesaving therapies more affordable and accessible to those in need.
Keren Haruvi, President of Sandoz North America, stated that TYRUKO® is the only biosimilar available in the US to treat multiple sclerosis, offering a more cost-effective way for patients to manage the disease and expanding the reach of natalizumab.
Leslie Ritter, Vice President of Healthcare Access for the National MS Society, emphasized that cost and access remain major barriers for MS patients, and the availability of this biosimilar is a crucial step toward making medications more affordable.
About Natalizumab
Natalizumab works by targeting the α4-integrin protein on the surface of immune cells, which plays a crucial role in allowing these cells to stick to and cross blood vessel walls into the brain and spinal cord. By binding to α4-integrin, natalizumab blocks this interaction, preventing immune cells from entering the central nervous system (CNS). This reduces inflammation and damage to the protective myelin sheath of nerve fibers, which is the main cause of symptoms in multiple sclerosis. As a result, natalizumab lowers relapse rates and slows disease progression in patients with relapsing forms of MS.
References
Sandoz launches TYRUKO® (natalizumab-sztn) in US, as first and only multiple sclerosis biosimilar, 17 November 2025, Sandoz, https://www.sandoz.com/sandoz-launches-tyrukor-natalizumab-sztn-us-first-and-only-multiple-sclerosis-biosimilar/
Polpharma Biologics Confirms U.S. Launch of Tyruko® (natalizumab), the First and Only Biosimilar for Multiple Sclerosis, 17 November 2025, Businesswire, https://www.businesswire.com/news/home/20251116413366/en/Polpharma-Biologics-Confirms-U.S.-Launch-of-Tyruko-natalizumab-the-First-and-Only-Biosimilar-for-Multiple-Sclerosis
Sellebjerg F, et al, Exploring potential mechanisms of action of natalizumab in secondary progressive multiple sclerosis, Ther Adv Neurol Disord. 2016 Jan;9(1):31-43. doi: 10.1177/1756285615615257. PMID: 26788129; PMCID: PMC4710106.