Pharma Focus America

Polpharma Biologics' Natalizumab Biosimilar receives groundbreaking CHMP Assessment for Multiple Sclerosis Treatment

Polpharma Biologics, an international biotech company specializing in biosimilar development and manufacturing, has recently received a positive evaluation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This evaluation paves the way for potential marketing authorization for their biosimilar natalizumab, designed for treating multiple sclerosis. The biosimilar has been developed by Polpharma Biologics in collaboration with Sandoz, their commercial partner.

The biosimilar natalizumab is a groundbreaking achievement, as it is the first of its kind for multiple sclerosis treatment. If granted marketing authorization, it will mirror the European indications of the reference medicine, which is a specific disease-modifying therapy (DMT) utilized in the treatment of highly active relapsing-remitting multiple sclerosis (RRMS) in adults. The biosimilar variant of natalizumab aligns precisely with the reference medication in terms of its intravenous (IV) dosage form, administration route, dosing regimen, and overall presentation. Polpharma Biologics provided comprehensive analytical, preclinical, and clinical data to the EMA to support their submission package. This included findings from both Phase I and Phase III ANTELOPE studies in RRMS patients. The results from these trials successfully met their primary objectives, demonstrating that the biosimilar is comparable to the reference medicine in terms of effectiveness, safety, and immunogenicity.

Multiple sclerosis stands as a persistent condition characterized by both chronic inflammation and neurodegeneration, impacting the central nervous system. Treating this disease requires ongoing care and can impose a significant financial burden on healthcare systems. The biosimilar natalizumab's potential approval could offer a more cost-effective option, thereby alleviating some of the economic strain. The estimated annual costs of treating moderate-to-severe cases of multiple sclerosis can be substantial, ranging from €37,000 to €57,000 per patient.

The CHMP's favorable recommendation marks a pivotal moment for patients seeking accessible and affordable treatment options. This scientific endorsement will be shared with the European Commission (EC), which will make a decision regarding EU-wide marketing authorization. Such an authorization, if granted, would be applicable not only to EU Member States but also to countries in the European Economic Area and Northern Ireland under the Northern Ireland Protocol.

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