Pharmamarketeer
Sandoz biosimilar receives EC approval to treat MS

Sandoz biosimilar receives EC approval to treat MS

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.

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