Polpharma Biologics has confirmed that Sandoz Tyruko (natalizumab-sztn) is now available to patients in the United States.
The biopharmaceutical company group, which focuses on biosimilar development and manufacturing, said the launch marks a significant milestone in expanding access to high-quality, affordable treatment options for patients living with multiple sclerosis (MS) and Crohn’s disease in the United States.
Tyruko is the first and only FDA-approved biosimilar of natalizumab for the treatment of relapsing forms of MS and also for adult patients with moderately to severely active Crohn’s disease.
Tyruko was developed by Polpharma Biologics and will be commercialised in the US 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, 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."
"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, a contract development and manufacturing organisation (CDMO) operating under the Rezon Bio brand, is responsible for the commercial supply of the drug substance for Tyruko.
Tyruko is now available in the US and 14 countries across Europe, representing a major step forward in broadening access to biological medicines for patients worldwide.