EMA accepts application for MS biosimilar natalizumab. from Polpharma Biologics

Biogen’s Tysabri was first approved in the EU as an intravenous formulation in 2006, while a subcutaneous formulation was approved last year. The drug made nearly $2.1 billion worldwide in 2021, making it one of the company’s best-selling products.

Phase 3 Data Support Application

The EMA application for natalizumab is for an intravenous (IV) route of administration, with the same dosage regimen, presentation and indication as the reference drug Tysabri – a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS).

The application was supported by analytical, preclinical and clinical data, including those from the Phase 3 Antelope study in RRMS patients. This study met the primary endpoints, “demonstrating that the proposed biosimilar was consistent with the efficacy and safety of the reference drug,” the company said.

Natalizumab was developed by Polpharma Biologics and the company remains responsible for manufacturing and supplying the drug. Sandoz has the rights to commercialize and distribute the proposed biosimilar under an exclusive worldwide license, secured by a commercialization agreement signed in 2019 between Polpharma Biologics and Sandoz.

“The acceptance of the submission of the proposed biosimilar natalizumab by the European regulatory authorities means we are a crucial step closer to getting this important drug to the patients who need it most. We are extremely proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration – this milestone is a testament to their achievements.”said Michael Soldan, CEO.

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