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

Amsterdam, The Netherlands, 25th of July 2022

Polpharma Biologics, an international biotech company dedicated to the development of biosimilars, announced today 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^®*, filed 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-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.¹ A Marketing Approval Application (MAA) for the proposed biosimilar natalizumab was also accepted by the European Medicines Agency (EMA) on 14 July 2022.

Multiple sclerosis (MS) is a chronic inflammatory neurodegenerative disease that is regarded as the foremost cause of nontraumatic neurologic disability in adults in North America, with a prevalence of approximately one case per 1000 population, and a predominance in women.  Although MS is heterogeneous, in the majority of patients - as many as 85% - it begins with episodic, largely reversible neurologic dysfunction, in a pattern termed relapsing-remitting MS.² The average total cost of living with MS in the U.S. is $88,487 per year, with the estimated cost to the U.S. economy, including direct and indirect healthcare costs, totaling as much as $85.4 billion per year.³

“Years of hard work on our proposed biosimilar of Tysabri^®* have culminated in this BLA submission that was accepted for review today by the U.S. FDA. I could not be more proud of our scientists, clinicians and regulatory experts who have made this milestone happen. Their dedication has taken us a major step closer to providing patients across the U.S. with access to this important treatment option,” said Michael Soldan, Chief Executive Officer, Polpharma Biologics Group.

The BLA submission was supported by a robust and comprehensive analytical, preclinical, and clinical data package, including evidence from the Phase III Antelope study in RRMS patients.⁴ The Antelope study met its primary endpoint, showing comparable efficacy for cumulative combined unique active (CUA) lesions. Together 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.

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 upon approval in the U.S. under an exclusive global license, secured through 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 impactful diseases across neurology, immunology, gastroenterology, 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. The expertise of Polpharma Biologics 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.

Leah Peyton
Director, Ruder Finn 
Lpeyton@ruderfinn.co.uk 
+44 7788 191434

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

1. Food and Drug Administration. Tysabri^® Highlights of Product Information. 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 Estimate 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 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)