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.

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 patented solutions and 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.