Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab

Published: 14.07.2022

Amsterdam, The Netherlands, 14th of July 2022

Polpharma Biologics, an international biotech company dedicated to the development of biosimilars, announced today that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri^®*. The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine Tysabri^® - a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).¹

Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease that can take a heavy toll on the quality of life of those affected. Up to half of all patients need to withdraw from employment within a decade of their diagnosis, need assistive walking devices within 15 years and are unable to walk 25 years after diagnosis.² Due to the high cost of therapies, the economic burden of MS is substantial - between €37,000-57,000 per patient, per year in those with moderate-to-severe disease.³

The MAA submission was supported by a robust analytical, preclinical and clinical data package, including evidence from the Phase III Antelope study in RRMS patients.⁴ The Antelope study, plus an earlier Phase I trial, both met their primary endpoints, demonstrating that the proposed biosimilar matched the efficacy and safety of the reference medicine.

Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz has the rights to commercialize and distribute the proposed biosimilar under an exclusive global license, secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

“The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most. We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration - today’s milestone is testament to their achievements,” said Michael Soldan, CEO. “Natalizumab is the second proposed biosimilar from our pipeline following ranibizumab** to have been successfully filed in Europe in the past year, showing the strength and depth of our product portfolio.”

Polpharma Biologics is focused on developing biosimilar therapies to treat some of the world’s most impactful diseases across neurology, immunology and ophthalmology. The company has a robust pipeline containing more than six biosimilars in different stages of development.

About Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products 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 center in the Netherlands, and two centers of development and manufacturing in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

Media contacts

Leah Peyton

Director, Ruder Finn

Lpeyton@ruderfinn.co.uk

+44 7788 191434

References

*Tysabri^® is a registered trademark of Biogen MA, Inc.

** A biosimilar ranibizumab (biosimilar to Lucentis^®) developed through Bioeq AG, joint venture company of Polpharma Biologics and Formycon, currently under review by the FDA and EMA. Lucentis^®is a registered trademark of Genentech Inc.

1. European Medicines Agency (EMA). Tysabri EPAR. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/Tysabri [Accessed June 2022]

2. Cohen JA, Rudick RA. Aspects of multiple sclerosis that relate to trial design and clinical management. In: Cohen JA, Rudick RA, Third ed. Multiple sclerosis therapeutics. Boca Raton, FL: Taylor & Francis, 2007

3. 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

4. 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 Supplement https://n.neurology.org/content/98/18_Supplement/1103)

written by: Polpharma Biologics

Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab

Amsterdam, The Netherlands, 14th of July 2022

About Polpharma Biologics

References

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