Sandoz obtains FDA nod for first Tysabri biosimilar

The Food and Drug Administration has given Sandoz the green light for Tyruko (natalizumab-sztn), the first biosimilar to Biogen's Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis.

Tyruko was developed by scientists at Polpharma Biologics and the company retains responsibility for manufacturing and supplying the drug substance.

Sandoz has the rights to commercialize and distribute the biosimilar under an exclusive global license secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's Disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α (tumor necrosis factor, a substance in your body that causes inflammation).

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"Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis," said Paul Lee, director of the division of Neurology 2 in the FDA's Center for Drug Evaluation and Research. "Today's approval could have a meaningful impact for patients managing their disease."

Tyruko is approved to treat the following relapsing forms of MS:

• Clinically isolated syndrome – a single, first occurrence of MS symptoms;
• Relapsing-remitting disease – a type of MS that occurs when patients have episodes of new neurological symptoms followed by periods of stability; and
• Active secondary progressive disease – when, following a relapsing-remitting course, patients experience gradual disability worsening with continued relapses.

"Today's approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost," said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research.

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MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of acquired neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability.