Sandoz biosimilar receives EC approval to treat MS
Sandoz has announced that its biosimilar, Tyruko (natalizumab), has been approved by the European Commission as a single disease-modifying therapy in adults with highly active relapsing forms of multiple sclerosis (MS).
Tyruko, developed by Polpharma Biologics, is now the first and only biosimilar for treating relapsing-remitting MS (RRMS) in Europe.
Affecting over one million people in the US, MS is a disabling and unpredictable neurological disease that disrupts communication between the brain and other parts of the body.
In August this year, the US Food and Drug Administration (FDA) approved Tyruko – a version of Tysabri (natalizumab) – which is currently the first and only FDA-approved biosimilar for people with MS.
The approvals were based on evidence from an extensive analytical and functional characterisation and results from a phase 1 PK/PD study and a phase 3 Antelope study in RRMS patients.
Both studies met their primary endpoints, proving that the biosimilar matched the reference biologic in relation to pharmacokinetics, as well as efficacy, safety and immunogenicity.