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FDA Approves First Biosimilar for Relapsing Forms of MS
The US Food and Drug Administration (FDA) recently approved Tyruko (natalizumab-sztn), the first biosimilar of Tysabri (natalizumab) injection, for the treatment of adults with relapsing forms of multiple sclerosis (MS).
Tyruko is approved as monotherapy to treat all indications covered by the reference biologic, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease. Tyruko has the same intravenous dosage form, route of administration, dosing regimen, and presentation as reference natalizumab.
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“The approval of Tyruko, the first FDA-approved biosimilar disease-modifying treatment for people with relapsing forms of MS, is a milestone,” said Bari Talente, executive vice president for advocacy and health care access at the National MS Society. “Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence, and help contain health care costs.”
The FDA granted Tyruko approval to Sandoz, based on evidence from phase 1 and phase 3 trials that showed no clinically meaningful differences between the biosimilar and reference biologic in terms of safety, purity, and potency.
Sandoz entered into a commercialization agreement with Tyruko developer Polpharma Biologics in 2019. Per the agreement, Polpharma Biologics maintains responsibility for the development, manufacturing, and supply of the active substance in Tyruko, and Sandoz has exclusive rights to commercialize and distribute it in all markets globally.
Like Tysabri, Tyruko is also indicated for Crohn disease in adults.
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