Polpharma Biologics Announces Approval of Europe’s First and Only Biosimilar for Multiple Sclerosis - Tyruko® (Natalizumab)

Polpharma Biologics Announces Approval of Europe’s First and Only Biosimilar for Multiple Sclerosis - Tyruko® (Natalizumab)

AMSTERDAM, The Netherlands, September 26, 2023 / B3C newswire / -- Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the European Commission (EC) has approved 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.(1)

Tyruko® received marketing authorization in Europe (1) 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).(2) Tyruko® was developed to have the same strength/dosage form, intravenous (iv) 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.”

MS is a progressive, chronic inflammatory, and neurodegenerative disease of the central nervous system (3), 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.(4)

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.(5) For Great Britain, a separate application for the use of biosimilar natalizumab in RRMS has been made to the Medicines and Healthcare products Regulatory Agency (MHRA), and a decision as to approval is imminent.

The robust analytical, preclinical, and clinical data submission package that supported this marketing authorization included both a Phase I PK/PD study and the confirmatory Phase III ANTELOPE study in RRMS patients.(6) Both studies met their primary endpoints, confirming that the biosimilar matched the reference medicine in terms of pharmacokinetics, as well as efficacy, safety, and immunogenicity.(1)

Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the drug substance. Sandoz has the right to commercialize and distribute Tyruko®, under an exclusive global license secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019. The EC approval is a result of close collaboration between Sandoz and Polpharma Biologics in the registration phase. Sandoz holds marketing authorization rights in the EU and U.S.

Polpharma Biologics is focused on broadening access to biological medicines used to treat some of the world’s most impactful diseases across neurology, immunology, and ophthalmology. The company is at the forefront of the next wave in biopharma, leveraging its knowledge, capabilities, and footprint to develop its robust pipeline of more than seven biosimilars in early-late-stage development.