Polpharma Biologics of Amsterdam, Netherlands, an international biotech company, announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for biosimilar natalizumab, a monoclonal antibody treatment for adults with highly active relapsing-remitting multiple sclerosis (RRMS).

Natalizumab is a proposed biosimilar to Tysabri®, and the application was for intravenous administration at the same dosage and indication as Tysabri.

“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,” Michael Soldan, chief executive officer of Polpharma Biologics, said.

“Natalizumab is the second proposed biosimilar from our pipeline following ranibizumab to have been successfully filed in Europe in the past year,”


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Positive evidence from a phase 1 trial and the phase 3 antelope study on patients with RRMS in which the primary endpoints were met comprised a vital part of the MAA submission. These trials showed conclusively that biosimilar natalizumab had the same efficacy and safety as the reference drug Tysabri.

Polpharma Biologics will manufacture and supply the compound while Sandoz has commercialization and distribution rights under an exclusive global license.

Reference

Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab. News release. Polpharma Biologics; July 14, 2022.