- Polpharma Biologics has confirmed that Tyruko®, the first FDA-approved biosimilar of natalizumab, is now available to patients in the United States.
- The company will supply the commercial drug substance as part of its CDMO operations under the Rezon Bio brand.
Polpharma Biologics has confirmed that Tyruko® (natalizumab-sztn), the first and only U.S. Food and Drug Administration-approved biosimilar of natalizumab, is now available to patients in the United States. The therapy is approved for relapsing forms of multiple sclerosis and for adult patients with moderately to severely active Crohn’s disease.
The biosimilar was developed by Polpharma Biologics and will be commercialised in the United States by Sandoz under an exclusive global licence agreement. According to the company, the launch represents a milestone in expanding access to high-quality and affordable biological medicines for patients in the U.S. market.
Emmanuelle Lepine, Chair of the Supervisory Board at Polpharma Biologics, said: “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.”
Polpharma Biologics S.A., operating as a contract development and manufacturing organisation 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 United States and in 14 countries across Europe, expanding patient access to biological therapies in both regions.
