Polpharma Biologics announces the acceptance of the dossier by the FDA for the review of natalizumab, the first biosimilar proposed to Tysabri®

AMSTERDAM, Netherlands, July 25, 2022 / B3C Newswire / — Polpharma biological products, an international biotechnology company dedicated to the development of biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has accepted the first-ever Biologics License Application (BLA) for natalizumab, a proposed biosimilar to Tysabri®*, registered by their collaboration partner Sandoz. The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine, Tysabri® (natalizumab) – a monotherapy for adult patients with relapsing multiple sclerosis -remitting (RRMS) and adults with moderately to severely active Crohn’s disease.1 A Marketing Authorization Application (MAA) for the proposed biosimilar natalizumab was also accepted by the European Medicines Agency (EMA) on July 14, 2022.

Multiple sclerosis (MS) is a chronic inflammatory neurodegenerative disease, which is considered the leading cause of non-traumatic neurological disability in adults in North America, with a prevalence of approximately one case per 1000 population and a predominance in the women. Although MS is heterogeneous, in the majority of patients – up to 85% – it begins with episodic, largely reversible neurological dysfunction in a pattern called relapsing-remitting MS.2 The average total cost of living with MS in the United States is $88,487 per year, with an estimated cost to the US economy, including direct and indirect healthcare costs, totaling up to $85.4 billion. dollars per year.3

“Years of hard work on our proposed Tysabri®* biosimilar culminated in this BLA submission which was accepted for review today by the US FDA. I couldn’t be prouder of our scientists, clinicians and regulatory experts who made this important milestone possible. Their dedication has allowed us to take a step closer to providing patients in the United States with access to this important treatment option,” said Michael Soldan, Chairman and CEO of Polpharma Biologics Group.

The BLA submission was supported by a robust and comprehensive analytical, preclinical and clinical data set, including evidence from the Phase III study of Antelope in patients with RRMS.4
The Antelope study met its primary endpoint, showing comparable efficacy for single active combined cumulative lesions (CUA). With the Phase I (PK/PD) study, which also met its primary endpoint, the studies demonstrated that the proposed biosimilar matched the efficacy and safety of the reference medicine.

The biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacture and supply of the drug. Sandoz has the rights to commercialize and distribute the proposed biosimilar after approval in the United States under an exclusive worldwide license, secured by a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

Polpharma Biologics is focused on developing biosimilar therapies to treat some of the world’s most important diseases in the fields of neurology, immunology, gastroenterology and ophthalmology. The company has a strong pipeline containing over six biosimilars in various stages of development.

About Polpharma biological products
Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and cutting-edge platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.
Polpharma Biologics programs begin with cell line development and progress from 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 manufacturing of drugs based on microbial and mammalian expression systems. With its cell line development center in the Netherlands and two development and manufacturing centers in Poland, Polpharma Biologics creates growth and development opportunities for biotechnology specialists.

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


Lea Peyton
Director, Ruder Finn
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1 Food and drug administration. Tysabri® Product Information Highlights. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf. Accessed June 13, 2022
2 Ransohoff Richard, Natalizumab for multiple sclerosis, N Engl J Med 2007;356;25:2622-2629.
3 The economic burden of multiple sclerosis in the United States Estimation of direct and indirect costs, Bebo B., Neurology May 2022, 98 (18) e1810-e1817; DOI: 10.1212/WNL.0000000000200150
4 Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of the proposed natalizumab biosimilar PB006 compared to Tysabri® in patients with relapsing-remitting multiple sclerosis: primary data from the phase III Antelope study (P6-4.003). Neurology. 03 May 2022; 98 (18 Supplementhttps://n.neurology.org/content/98/18_Supplement/1103

Keywords: Humans; Adult; Natalizumab; Biosimilar Pharmaceuticals; Relapsing-remitting multiple sclerosis; the United States Food and Drug Administration; multiple sclerosis; Crohn’s disease; neurodegenerative diseases; Biotechnology; United States; North America

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