Novartis’ Sandoz receives FDA approval for Tyruko biosimilar for MS

Sandoz, a Novartis division, announced that the U.S. Food and Drug Administration has approved its biosimilar Tyruko, 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,” or MS, the company stated. Keren Haruvi, President North America, Sandoz Inc., said: “Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.” 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.