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.
A biosimilar is a biological product that is highly similar to one already approved. Patients can expect the same safety and efficacy from the biosimilar as they would from the reference product, while possibly benefitting from lower healthcare costs.
Administered as an injection, Tyruko has been approved as a monotherapy to treat all relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease in adults.
Rebecca Guntern, president Europe, at Sandoz, said: “Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential. Today’s approval brings us one step closer to reducing the burden of this disease for those living with multiple sclerosis in Europe by making the life-enhancing treatments they need more accessible.”
In 2019, Sandoz and Polpharma Biologics entered into a global commercialisation agreement for the biosimilar. As part of the deal, Polpharma will maintain responsibilities for the development of medicine, manufacturing and supply of the biosimilar, and Sandoz has the rights to commercialise and distribute it in all markets through an exclusive global licence.