Sandoz has announced the launch of Tyruko (natalizumab), which was developed by Polpharma Biologics and claimed to be the first and only biosimilar to treat relapsing remitting multiple sclerosis (RRMS), in Germany.
Tyruko is indicated as a single disease-modifying therapy (DMT) for adults diagnosed with highly active RRMS. This is the same indication that was approved by the European Commission for reference medicine Tysabri.
Sandoz president for Europe Rebecca Guntern 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 high efficacy DMTs continues to be limited given that only about 20% of people living with MS in Europe are able to leverage these new treatments. This count is significantly lower in Eastern European countries, with only about 3% to 4%, according to studies.
Sandoz emphasises the need for early and unrestricted access to these essential medicines to prevent irreversible neurological damage and delay disease progression.
In 2019, Sandoz entered into a global commercialisation agreement with Polpharma Biologics for the biosimilar natalizumab.
Under this partnership, Polpharma Biologics retains responsibility for the development, manufacturing, and supply of the drug substance.
Sandoz, through an exclusive global license, holds the rights to commercialise and distribute Tyruko in all markets, potentially broadening the reach of this important treatment option for RRMS patients.
The company provides patients access to critical biologic medicines across a range of areas including immunology, oncology, supportive care, endocrinology and neurology.
Sandoz has a portfolio with nine marketed biosimilars and another 24 assets in various stages of development.