Sandoz launches first and only biosimilar for multiple sclerosis, Tyruko (natalizumab) in Germany

Developed by Polpharma Biologics, Tyruko is the first and only biosimilar to treat RRMS. (r/r Multiple Sclerosis). Tyruko is indicated as a single disease-modifying therapy (DMT) in adults with highly active RRMS. This is the same indication as approved by the European Commission for reference medicine Tysabri.

Rebecca Guntern, President Europe, Sandoz, said: “Early treatment with disease-modifying therapies can have a significant impact on people living with multiple sclerosis and their potential future disabilities. As the first and only biosimilar in this space, the availability of Tyruko is a crucial milestone in improving access to effective and safe therapies for those in Europe that need them most.”

Access to novel high efficacy DMTs remains restricted with only roughly 20% of people living with MS in Europe able to make use of these innovative treatments. This number is significantly lower in Eastern European countries, roughly 3% to 4%. This highlights that more must be done to ensure early and unrestricted access to these crucial medicines so that irreversible neurological damage and disease progression can be delayed."

Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility 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.