Sandoz has been granted marketing authorization by the European Commission (EC) for the biosimilar Tyruko (natalizumab), developed by Polpharma Biologics.
The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS), the same indication as approved by the EC for the reference medicine Tysabri (natalizumab).
Rebecca Guntern, President Europe, Sandoz, said: “Multiple sclerosis (MS) 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.