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EC approves Polpharma Biologics’ Tyruko biosimilar for MS

Polpharma Biologics, an international biotech company focused on developing and manu­facturing biosimilars, has received approval from the European Commission for Tyruko (natalizumab) as the first and only biosimilar for relapsing forms of multiple sclerosis (MS) in Europe. Tyruko was developed by Polpharma Biologics and will be commercialized by its collaboration partner Sandoz.

Tyruko is biosimilar to Tysabri, a laboratory-produced monoclonal antibody. Tyruko received marketing authorization in Europe as a single disease-modifying therapy (DMT) in adults with highly active relapsing remitting MS (RRMS), the same indication as approved by the EC for the reference medicine Tysabri (natalizumab). Tyruko was developed to have the same strength/dosage form, intravenous route of administration, dosing regimen, and presentation as Tysabri – an established, highly effective anti-α4 integrin monoclonal antibody DMT. “We are delighted that the European approval of Tyruko comes hot on the heels of approval in the U.S, meaning that millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease,” said Michael Soldan, Chief Executive Officer, Polpharma Biologics Group. “Tyruko is the second EMA and FDA-approved biosimilar produced by Polpharma Biologics and the first one developed entirely in-house. We’re building on this extensive scientific and manufacturing expertise to further advance our pipeline of other high potential biosimilar targets.”

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MS is a progressive, chronic inflammatory, and neurodegenerative disease of the central nervous system, that can take a heavy toll on the lives of those affected. MS cannot be cured, but treatments can modify the course of disease. Due to the high costs of medication, broader access to more affordable treatment options is needed to reduce the substantial economic impact of MS on healthcare systems – which is estimated to be as much €37,000-€57,000 per patient per year, in both direct and indirect costs for those with moderate-to-severe disease.

EU marketing authorization through the centralized procedure is valid in all EU Member States, as well as the European Economic Area countries Iceland, Liechtenstein, Norway, and Northern Ireland under the Northern Ireland Protocol. Outside Europe, Tyruko was approved by the U.S. Food and Drug Administration (FDA) in August 2023. For Great Britain, approval is pending.

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