The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko®* (natalizumab).
The anti-α4 integrin monoclonal antibody is approved as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS) in Europe.
It covers the same indication approved by the EC for the reference medicine Tysabri®* (natalizumab).
This recent decision by the EC follows approval of Tyruko® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. The authorisation was also granted as treatment for other forms of the disease.
“Multiple sclerosis is a chronic condition with no cure at present and timely access to affordable, high-quality healthcare is therefore even more essential.” The approval is another step 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,” stated Rebecca Guntern, President Europe, Sandoz.
Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Sandoz has the rights to commercialise and distribute it in all markets under the deal. Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing and supply of drug substance.
The regulatory package submitted to the EC included evidence derived extensive analytical characterisation. This was in addition to Phase I PK/PD study results and a confirmatory Phase III Antelope study in RRMS patients. Both studies confirmed that the biosimilar matched the reference biologic for pharmacokinetics as well as efficacy, safety and immunogenicity. Tyruko® has the same strength/dosage form, intravenous (IV) route of administration, dosing regimen and presentation as the reference medicine, according to Sandoz.
* Tysabri® is a registered trademark of Biogen MA, Inc.
Advancing biosimilar development
Sandoz announced in July 2023 it intended to invest approximately $90 million in a new Slovenia-based biosimilar development facility. The company declared that this move would help to advance future growth of its biosimilar pipeline. The site is planned to be completed by 2026.
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