Polpharma Biologics announces FDA file acceptance for review of natalizumab


Polpharma Biologics announces that the US 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.

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.

The average total cost of living with MS in the US is $88,487 per year, with the estimated cost to the US economy, including direct and indirect healthcare costs, totalling as much as $85.4 billion per year.

“Years of hard work on our proposed biosimilar of Tysabri have culminated in this BLA submission that was accepted for review today by the US 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 US 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.

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 commercialise and distribute the proposed biosimilar upon approval in the US under an exclusive global license, secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

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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.