FDA nod for Tyruko, first biosimilar for relapsing forms of multiple sclerosis

Switzerland-based Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics.

Tyruko is approved to treat all indications covered by the reference medicine, US biotech firm Biogen’s (Nasdaq: BIIB) injectable Tysabri, and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). Global sales of Tysabri were $2.03 billion in 2022.

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.”