Sandoz, a division of the Novartis Group, has received US Food and Drug Administration (FDA) approval for its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics, to treat relapsing forms of multiple sclerosis (MS).
Tyruko, a biosimilar to Tysabri (natalizumab), is said to be a highly effective anti-α4 integrin monoclonal antibody disease-modifying therapy.
It is now said to be the first and only FDA-approved biosimilar for relapsing forms of MS.
Tyruko is approved as a monotherapy for all indications covered by the reference drug including relapsing-remitting MS (RRMS), clinically isolated syndrome (CIS), active secondary progressive disease, and Crohn’s disease in adult patients.
Sandoz North America president Keren Haruvi 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.”
The approval was based on a strong data package that included functional, analytical and clinical data.
According to the US health regulator, Tyruko demonstrated no clinically meaningful differences between the two products in terms of safety, purity and potency.
The FDA’s approval is complemented by labelling with safety warnings and a Risk Evaluation and Mitigation Strategy (REMS).
Tyruko’s intravenous (IV) dose form, method of administration, dosing schedule, and presentation are identical to those of the reference drug, Sandoz said.
The latest biosimilar will be made available through the Sandoz REMS programme after its launch.
FDA Centre for Drug Evaluation and Research Division of Neurology 2 director Paul Lee said: “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis.
“Today’s approval could have a meaningful impact on patients managing their disease.”
The therapy’s global commercialisation agreement was signed by Novartis’ spin-off and Polpharma Biologics in 2019.
Under the terms of the agreement, Polpharma Biologics will continue to oversee designing, producing, and supplying the active ingredient in Tyruko.
