FDA Approves Biosimilar to Treat Multiple Sclerosis

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This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

On Aug 24, 2023, FDA approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri, an injection for adults with relapsing forms of multiple sclerosis (MS). Tyruko is a biosimilar to Tysabri (natalizumab) used in adult patients with moderate to severe active Crohn’s disease (CD) with inflammation symptoms who are unable to receive normal CD therapies. Tyruko was approved to treat three types of MS: clinically isolated syndrome (a singular, initial emergence of MS symptoms), relapsing-remitting disease (episodes of new neurological symptoms and then periods of stability), and active secondary progressive disease (it occurs after a relapsing-remitting course, where patients’ disability gradually worsens with additional relapses).

The approval of Tyruko supports FDA’s mission to cultivate competition in the biological marketplace, giving more patients access to safe and high-quality medications at a more affordable price point. FDA’s approval is based on evidence that there is no meaningful difference between Tyruko and Tysabri’s safety, purity, and potency.

MS is a chronic inflammatory autoimmune disease of the central nervous system that interferes with signals between the brain and the rest of the body. It is more common in women than men and is one of the most common neurological disabilities in young adults. Often relapses, episodes of declining function and new symptoms, are followed by remissions, or recovery periods. As time goes on recovery may falter, which leads to a decline in function and an increase in disability.


Natalizumab products (Tyruko and Tysabri included) have a warning on the increased risk of progressive multifocal leukoencephalopathy, which is a viral infection in the brain that typically leads to severe disability or death. Because of this risk, natalizumab products are only available through a drug distribution program and are only given to patients enrolled in a risk evaluation and mitigation strategy (REMS). Patients must be evaluated by REMS-certified prescribers for three to six months before the first infusion, every six months after, as well as immediately and six months after stopping the treatment. Additional information and warnings pertaining to natalizumab products can be found on the FDA’s website.

FDA’s approval of Tyruko was granted to Sandoz.

Source: FDA