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Sandoz launches first and only multiple sclerosis biosimilar in US

The treatment is FDA-approved to treat MS and Crohn’s disease
- PMLiVE

Sandoz has announced that Tyruko, the first and only FDA-approved biosimilar for multiple sclerosis (MS), is now available in the US. Tyruko has been approved to treat relapsing forms of MS, such as clinically isolated syndrome and relapsing-remitting MS and is also available in 14 European countries.

Developed by Polpharma Biologics, Tyruko (natalizumab-sztn) is a biosimilar of natalizumab. It has been approved as a monotherapy to treat relapsing forms of MS, as well as Crohn’s disease. It is a monoclonal antibody that works by binding to immune cells in the bloodstream and preventing them from entering the central nervous system, thus minimising the nerve damage that characterises MS.

MS is an autoimmune condition in which the body’s immune system attacks and degrades the protective myelin that covers the brain and spinal cord. Common symptoms include muscle weakness, fatigue, difficulty with movement and cognitive difficulties.

Keren Haruvi, president of Sandoz North America, said: “As the only biosimilar available to treat multiple sclerosis in the US, Tyruko has an important opportunity to help people with MS navigate this disease in a way that is more cost effective.”

Leslie Ritter, vice president of healthcare access for the US-based National MS Society, said: “For people living with multiple sclerosis, cost and access to care remain significant barriers. The availability of a biosimilar is an important step forward in making medications more affordable.”

Esme Needham
27th November 2025
2025 T40 open for submissions
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