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Tyruko (natalizumab) is the first and only biosimilar for Multiple Sclerosis.
November 17, 2025
By: Rachel Klemovitch
Assistant Editor
Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, confirmed that Sandoz Tyruko (natalizumab-sztn) is now available to patients in the United States.Â
Tyruko is the first and only FDA-approved biosimilar of natalizumab to treat relapsing forms of multiple sclerosis (MS), and also for adult patients with moderately to severely active Crohn’s disease.
Tyruko will be commercialized in the U.S. by its collaboration partner Sandoz, under an exclusive global license agreement.Â
Polpharma Biologics S.A., operating under the Rezon Bio brand and headquartered in Gdańsk, Poland, is responsible for the commercial supply of the drug substance for Tyruko.
The launch marks a significant milestone in expanding access to high-quality, affordable treatment options for patients living with MS and Crohn’s disease in the United States.
Tyruko is now available in the U.S. and 14 countries across Europe, representing a major step forward in broadening access to biological medicines for patients worldwide.
Emmanuelle Lepine, Chair of the Supervisory Board, Polpharma Biologics, commented: “The U.S. launch of Tyruko marks a pivotal moment not only for Polpharma Biologics, but for patients across the United States. This milestone reflects our long-term commitment to scientific excellence, global collaboration, and expanding access to high-quality biologic therapies. Tyruko is a testament to the competency and dedication of our teams, and we are proud to see our biosimilar reach patients in need of more affordable treatment options.”
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