Polpharma Biologics announces approval of Europe’s first and only biosimilar for multiple sclerosis - Tyruko® (natalizumab)

Amsterdam, The Netherlands, 26th September 2023

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.

Tyruko^® received marketing authorization in Europe¹ 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 asTysabri^®* - 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, 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 ExecutiveOfficer, 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.³ 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 – 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, and 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 commercialise 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.

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), that leads in the development and manufacture of biosimilar medicines. Polpharma Biologics develops biosimilar therapies to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. Polpharma Biologics expertise lies in the development and manufacture of medicines based on microbial and mammalian expression systems. With its cell line development centre in the Netherlands and two centres of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Disclaimer

This press release is issued from Polpharma Biologics Group B.V. and is intended to provide worldwide information about our global business in relation to drug development and manufacturing expertise. Although Polpharma Biologics Group B.V. is not a public company as of this date, recipients should understand that this press release contains certain forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). These statements involve inherent risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the approval and commercialization of the medicinal product, market reception, competition, changes in economic conditions and applicable laws, global regulatory developments, contractual risks and dependencies from third parties. Polpharma Biologics undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release. Moreover, Polpharma Biologics wishes to emphasize that this press release is for informational purposes only and shall not be construed as making any representation, warranties, or guarantees, either express or implied, regarding the potential approval, market reception, commercialization, or success of the medicinal product or any other product or therapy.

Media contacts

Leah Peyton
Head of Healthcare, Ruder Finn
Lpeyton@ruderfinn.co.uk
+44 7788 191434

References

1. Tyruko^® (natalizumab) EU Summary of Product Characteristics, September 2023. Available from:https://www.ema.europa.eu/en [Accessed September 2023]

2. European Medicines Agency (EMA). Tysabri EPAR. Available from:https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed September 2023]

3. MS International Federation. What is MS? October 2021. Available from: https://www.msif.org/about-ms/what-is-ms/[Accessed September 2023]

4. Kobelt G, Thompson A, Berg J, et al. New insights into the burden and costs of multiple sclerosis in Europe. Mult Scler.2017;23(8):1123-1136. doi:10.1177/1352458517694432

5. Tyruko. Prescribing Information 2023.http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=761322

6. Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed natalizumab biosimilar PB006 versus Tysabri^® in patients with relapsing remitting multiple sclerosis: Primary data from the Phase III Antelope study (P6-4.003). Neurology.May 03, 2022; 98 (18 Supplementhttps://n.neurology.org/content/98/18_Supplement/1103