August 25, 2023
USFDA approves Sandoz’s Tyruko, developed by Polpharma Biologics, EMA’s approval expected
The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Approval of Tyruko by the European Medicines Agency is also expected imminently.