Sandoz receives European Commission approval for Tyruko, first and only biosimilar of Tysabri

Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko® (natalizumab), developed by Polpharma Biologics. The European approval for Tyruko comes a month after the US Food and Drug Administration (FDA) approval.

Tyruko was originally developed by Polpharma Biologics, with Sandoz acquiring the exclusive global commercialisation rights from the former in 2019. As per the agreement, Polpharma is responsible for the development, manufacturing, and supply of the drug, whilst Sandoz bears responsibility for distribution and commercialisation. According to Polpharma, Tyruko is authorized for adults with highly active relapsing remitting multiple sclerosis, the same indication as Tysabri in Europe. It has the same strength, dosage and intravenous administration as Tysabri.

Rebecca Guntern, President Europe, Sandoz, said: “Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today’s approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life-enhancing treatments they need more accessible.”

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