Monday, July 15, 2024

European Commission Approves Initial and Exclusive Biosimilar for Multiple Sclerosis Treatment by Sandoz

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Sandoz has secured approval from the European Commission (EC) for its biosimilar Tyruko® (natalizumab), marking a significant milestone as the first and sole biosimilar for the treatment of relapsing forms of multiple sclerosis (MS) available in Europe. This approval pertains to treating adults with highly active relapsing-remitting multiple sclerosis (RRMS), mirroring the indication of the reference medication Tysabri® (natalizumab). The EC’s decision to greenlight Tyruko® was underpinned by an extensive analytical assessment demonstrating its likeness to the reference biologic. Moreover, it was supported by positive outcomes from Phase I and confirming Phase III studies.

Multiple sclerosis is a chronic condition characterized by inflammation and neurodegeneration, profoundly affecting daily life. Administering disease-modifying therapies (DMTs) early in the disease’s course can modify its trajectory and mitigate future disability. However, equitable access to DMTs is not universally available, and the cost of MS medications presents a barrier in numerous countries.

Sandoz’s unwavering dedication to delivering cost-effective, high-quality biosimilars aligns with its mission to broaden access to vital treatments and generate cost savings for healthcare systems and patients across the globe. Tyruko® was meticulously developed to match the reference medicine’s efficacy, safety, and immunogenicity, presenting patients with an accessible and efficacious treatment alternative for RRMS.

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