FDA approves Tysabri biosimilar Tyruko for relapsing forms of multiple sclerosis

The FDA has approved Tyruko, the first biosimilar to Tysabri injection, for the treatment of adults with relapsing forms of multiple sclerosis.

Tyruko (natalizumab-sztn, Sandoz) has been cleared to treat clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease — all relapsing forms of MS, according to a press release from the FDA.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” Paul R. Lee, MD, PhD, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research (CDER), said in the release. “Today’s approval could have a meaningful impact for patients managing their disease.”

Approval of Tyruko was based on evidence showing no clinically meaningful differences between it and Tysabri (natalizumab, Biogen) regarding safety and efficacy, per the release. A biosimilar is a product that is alike but possesses no clinically meaningful differences from what has already been approved by the FDA.

“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,” Sarah Yim, MD, director of the CDER’s Office of Therapeutic Biologics and Biosimilars, said in the release.