Sandoz said that the U.S. Food and Drug Administration approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis.
Multiple sclerosis or MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect daily life. Most people with MS experience periods of new symptoms or relapses that improve partially or completely, followed by periods of disease remission.
Tyruko is approved as a monotherapy to treat all indications covered by reference medicine Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn's disease in adults.
Sandoz reached into a global commercialization agreement for Tyruko with Polpharma Biologics in 2019. As per the agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply of the active substance in Tyruko. Sandoz has the rights to commercialize and distribute it in all markets.
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