Pharma Focus Europe

Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab

Friday, July 15, 2022

Polpharma Biologics, an international biotech company specializing in biosimilar development, announced today that the European Medicines Agency (EMA) has officially accepted the Marketing Authorization Application (MAA) for biosimilar natalizumab, which aims to be a comparable version of Tysabri®*. This significant milestone marks the first-ever MAA acceptance for a biosimilar of natalizumab, offering an intravenous (IV) route of administration with the same dosing regimen, presentation, and indication as the reference medicine Tysabri®. The latter is recognized as a singular disease-modifying therapy (DMT) for adults with highly active relapsing-remitting multiple sclerosis (RRMS)^1.

Multiple sclerosis (MS), a chronic inflammatory and neurodegenerative disease, significantly impacts the quality of life for those affected. Within a decade of diagnosis, up to half of all patients may need to withdraw from employment, require assistive walking devices within 15 years, and find themselves unable to walk 25 years after diagnosis^2. Due to the high cost of MS therapies, the economic burden on individuals with moderate-to-severe disease amounts to approximately €37,000-57,000 per patient per year^3.

The MAA submission for biosimilar natalizumab encompassed a comprehensive package of analytical, preclinical, and clinical data, including findings from the Phase III Antelope study involving RRMS patients^4. Both the Antelope study and an earlier Phase I trial successfully met their primary endpoints, demonstrating that the proposed biosimilar matches the efficacy and safety of the reference medicine.

Polpharma Biologics' team of scientists developed biosimilar natalizumab and continues to assume responsibility for its manufacturing and supply. Under an exclusive global license secured through a 2019 commercialization agreement between Polpharma Biologics and Sandoz, Sandoz holds the rights to commercialize and distribute the proposed biosimilar.

"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," stated Michael Soldan, CEO of Polpharma Biologics. "Natalizumab is the second proposed biosimilar from our pipeline, following ranibizumab**, to have been successfully filed in Europe in the past year, showcasing the strength and depth of our product portfolio."

Polpharma Biologics maintains its focus on developing biosimilar therapies to address some of the most impactful diseases in the fields of neurology, immunology, and ophthalmology. The company boasts a robust pipeline comprising more than six biosimilars in various stages of development.

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