Polpharma Biologics Confirms U.S. Launch of Tyruko® (natalizumab), the First and Only Biosimilar for Multiple Sclerosis

Polpharma Biologics, a biopharmaceutical company group focused on biosimilars development and manufacturing, today confirmed that Sandoz Tyruko^® (natalizumab-sztn) is now available to patients in the United States. Tyruko^® is the first and only FDA-approved biosimilar of natalizumab for the treatment of relapsing forms of multiple sclerosis (MS), and also for adult patients with moderately to severely active Crohn’s disease¹.

Tyruko^® was developed by Polpharma Biologics and will be commercialized in the U.S. by its collaboration partner Sandoz, under an exclusive global license agreement. 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.

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."

Polpharma Biologics S.A., a contract development and manufacturing organization (CDMO) operating under the Rezon Bio brand and headquartered in Gdańsk, Poland, is responsible for the commercial supply of the drug substance for Tyruko^®.

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.

About Polpharma Biologics

Polpharma Biologics is a group of biopharmaceutical companies focused on development and manufacturing of biopharmaceuticals and biosimilars for supply to global markets. Our Swiss based biosimilars focused entity manages the entire value chain: from product selection and investment allocation, through program execution to asset monetization, ensuring fast progress from idea to launch in strong collaboration with our global partners.

Our international team of senior experts has proven experience in program leadership, regulatory strategy, CMC integration, device development, clinical oversight, and quality assurance. Working with trusted CDMOs, we deliver end-to-end biosimilars, from cell line to finished product, across a range of major therapeutic areas. Our commercial partners ensure access for patients to these medicines worldwide. Our mission is to accelerate access to biologics. To fulfill that mission, we maintain a robust, expanding pipeline of biosimilars in development.

¹ For full prescribing information, please refer to the US FDA Prescribing Information for Tyruko^®

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