Sandoz Secures European Commission Approval for Tyruko® (Natalizumab): Europe's First Biosimilar for Multiple Sclerosis

Tuesday, September 26, 2023

Sandoz, a prominent player in the realm of generic and biosimilar medicines, has achieved a significant milestone with the European Commission (EC) granting marketing authorization for Tyruko® (natalizumab), a biosimilar developed by Polpharma Biologics. This authorization specifically allows the use of Tyruko® as a standalone disease-modifying therapy (DMT) for adults dealing with highly active RRMS, aligning with the indication already approved by the EC for the reference medication, Tysabri®* (natalizumab).

Rebecca Guntern, President of Sandoz Europe, underscored the significance of accessible and high-quality healthcare for individuals living with multiple sclerosis (MS), a chronic condition that currently lacks a cure. She said, "Today's endorsement marks progress in our mission to reduce the impact of multiple sclerosis on people in Europe. It enhances accessibility to the life-enhancing treatments they require." MS is a chronic inflammatory and neurodegenerative disorder of the central nervous system that significantly impacts daily life. It typically involves periods of relapses characterized by new or worsening symptoms, followed by periods of disease remission where symptoms may partially or completely improve. Early treatment with DMTs has the potential to alter the disease's course and reduce future disability. However, access to DMTs is not uniform, with the Atlas of MS Report indicating that 72% of countries face barriers to access, and the cost of MS medications serves as a significant obstacle in many regions.

In 2019, Sandoz entered into a global commercialization agreement for the biosimilar natalizumab with Polpharma Biologics. Under this agreement, Polpharma Biologics retained responsibility for medicine development, manufacturing, and drug substance supply, while Sandoz secured exclusive global rights for commercialization and distribution across all markets.

The comprehensive regulatory submission for Tyruko® included extensive analytical and functional characterization evidence, along with data from a Phase I PK/PD study and a confirming Phase III Antelope study conducted in RRMS patients. Both studies successfully met their primary endpoints, confirming that Tyruko® matches the reference biologic in terms of pharmacokinetics, efficacy, safety, and immunogenicity. Tyruko® shares the same strength, dosage form, intravenous (IV) route of administration, dosing regimen, and presentation as the reference medicine.

Sandoz remains dedicated to enhancing access to critical biologic medicines for millions of patients in various therapeutic areas, including immunology, oncology, supportive care, and endocrinology, all while ensuring sustainability and affordability. With eight biosimilars already on the market and an additional 25 assets in various developmental stages, Sandoz has played a key role in providing early and expanded patient access to life-altering medicines, increasing healthcare savings, and fostering competition that drives further innovation since launching the first biosimilar in Europe in 2006.


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