Tyruko biosimilar to treat adults with highly active relapsing remitting multiple sclerosis (RRMS)
Launch strengthens well-established Sandoz biosimilar portfolio in Europe. (Credit: MasterTux from Pixabay)
Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Tyruko (natalizumab) in Germany from February 1. Developed by Polpharma Biologics, Tyruko is the first and only biosimilar to treat RRMS.
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%.3 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.
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, endocrinology and now also neurology.
It has a leading global portfolio with nine marketed biosimilars and a further 24 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 improving healthcare through savings and creating competition that fuels further innovation.
Source: Company Press Release