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Sandoz Achieves FDA Green Light for Tyruko®- Pioneering Biosimilar for Treating Relapsing Multiple Sclerosis

Sandoz, a prominent player in the global pharmaceutical industry specializing in generic and biosimilar medicines, has announced a significant milestone. The US Food and Drug Administration (FDA) has granted its approval for Tyruko® (natalizumab-sztn), a biosimilar developed in collaboration with Polpharma Biologics. Tyruko is now authorized to treat all the conditions covered by the reference medication and stands as the first and sole FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS) in the United States.

With almost one million individuals in the US grappling with multiple sclerosis, a significant portion of them experiences disease relapse. Tyruko has the potential to widen access to natalizumab treatment for these patients, leading to cost savings in healthcare and stimulating competition in the market, thereby fostering innovation.

Tyruko has secured as a monotherapy for the entire spectrum of indications encompassed by its reference counterpart, Tysabri®* (natalizumab). Tyruko represents a milestone as it marks the first FDA-approved biosimilar for disease-modifying treatment in people with relapsing forms of MS. Biosimilars play a vital role in healthcare as they exhibit no clinically significant differences from their reference medicines. Prescribing them can enhance medication accessibility, promote better adherence, and contribute to controlling healthcare costs.

Notably, Tyruko shares the same intravenous (IV) dosage form, route of administration, dosing regimen, and presentation as its reference medication. Sandoz places a strong emphasis on ensuring patient safety throughout the Tyruko experience.

Tyruko has been meticulously developed to closely resemble the reference medicine—an established and highly effective anti-α4 integrin monoclonal antibody disease-modifying treatment for relapsing forms of multiple sclerosis (MS). In the United States, Tyruko is designated as a monotherapy for relapsing forms of MS, encompassing clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease, along with its approval for Crohn’s disease in adults. This significant achievement marks Tyruko as the premier and only FDA-approved biosimilar tailored for addressing relapsing forms of MS.

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