Medical Xpress August 27, 2023
The U.S. Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced Thursday.
Tyruko was approved to treat adults with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Like Tysabri, the biosimilar is also indicated for treating moderately to severely active Crohn disease in patients who do not respond to or tolerate conventional Crohn disease therapies or tumor necrosis factor-alpha inhibitors.
“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, M.D., Ph.D., of the FDA Center for Drug Evaluation and Research, said in an agency...
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