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Polpharma Biologics' Groundbreaking Biosimilar for Multiple Sclerosis, Natalizumab, Garners Positive CHMP Opinion

Monday, July 24, 2023

Polpharma Biologics, a renowned international biotech company specializing in biosimilars, has recently made a significant announcement regarding their innovative product. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the marketing authorization of natalizumab, which is a first-of-its-kind biosimilar developed by Polpharma Biologics for the treatment of multiple sclerosis. Collaborating with Sandoz, Polpharma Biologics plans to commercialize this biosimilar.

Upon approval, the marketing authorization for natalizumab will align with the European indication for its reference medicine. The biosimilar is a disease-modifying therapy (DMT) designed to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). It has the same intravenous (IV) dosage form, route of administration, dosing regimen, and presentation as the reference medication. The comprehensive submission package to the EMA included data from Phase I and Phase III ANTELOPE studies in RRMS patients, demonstrating comparable efficacy, safety, and immunogenicity to the reference medicine.

Multiple sclerosis is a chronic inflammatory and neurodegenerative disease of the central nervous system, necessitating lifelong treatment and incurring substantial healthcare costs. Therefore, the approval of this biosimilar offers the potential for more affordable treatment options, which can significantly reduce the economic burden of multiple sclerosis on healthcare systems. The positive CHMP opinion represents a milestone for patients seeking accessible and life-changing treatment options.

Polpharma Biologics' CEO, Michael Soldan, expressed pride in this achievement, highlighting that natalizumab is the second biosimilar from their Development and Production Center to receive approval from European regulatory authorities. He emphasized their commitment to further advancing their biosimilars pipeline, with the goal of providing affordable access to critical medicines.

The positive CHMP opinion is a scientific recommendation that will now be considered by the European Commission (EC) for the adoption of a decision on EU-wide marketing authorization. If approved, the biosimilar will be valid in all EU Member States and the European Economic Area countries. Separate applications will be made for its use in Great Britain and the United States, with the Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA), respectively.

The biosimilar natalizumab was developed entirely by Polpharma Biologics' scientists, and the company will handle its manufacturing and supply. Meanwhile, Sandoz holds the rights to commercialize and distribute the biosimilar globally through an exclusive license secured via a 2019 commercialization agreement between the two companies.

Polpharma Biologics is dedicated to expanding access to biological medicines for impactful diseases in neurology, immunology, and ophthalmology. With a robust pipeline comprising more than seven biosimilars in various stages of development, they strive to make a positive impact on global healthcare.

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