Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe

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 authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EC for the reference medicine Tysabri (natalizumab).

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.”

MS is a chronic inflammatory and neurodegenerative disease of the central nervous system that can drastically affect daily life. Most people living with MS experience periods of new or worsening of existing symptoms known as relapses followed by periods of disease remission, when the symptoms improve partially or completely. Early treatment with DMTs can change the course of a person’s MS and reduce future disability. However, access to DMTs is not universal; 72% of countries cite barriers to accessing DMTs and the cost of MS medicines is a barrier to access in many countries, according to the Atlas of MS Report.

Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets.

The comprehensive regulatory submission package included evidence derived from an extensive analytical and functional characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III Antelope study in RRMS patients. Both studies met their primary endpoints, confirming that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity. Tyruko has the same strength/ dosage form, intravenous (IV) route of administration, dosing regimen and presentation as the reference medicine.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation.