Approvals

Novartis’ Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. The drug is approved for the treatment of all indications covered by its reference medication, Tysabri, and is the only biosimilar to be approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS).

As well as relapsing forms of MS, Tyruko is approved for the remaining indications of its reference, Tysabri, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease and Crohn’s disease in adults.

Keren Haruvi, president North America at Sandoz, commented: “Of the nearly one million people in the US living with MS, 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.”

“Accesstoaffordable,high-qualityhealthcare is essential for people with MS to live their best lives,” stated Bari Talente, the National MS Society’s executive vice president for Advocacy and Healthcare Access. “The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone. Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs.”