First ever Marketing Authorisation Application (MAA) for biosimilar natalizumab

Polpharma Biologics announced on July 15th 2022 that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorisation Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri®.

In the European Union, Tysabri is approved to treat adults with relapsing-remitting MS (RRMS) who have highly active disease. It is approved for adults with relapsing forms of MS in the US.

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

The MAA submission was supported by a robust analytical, preclinical and clinical data package, including evidence from the Phase III Antelope study in RRMS patients (NCT04115488). 

Antelope trial results, presented at this year’s American Academy of Neurology (AAN) annual meeting, broadly showed that the biosimilar was comparable to Tysabri in terms of its efficacy at reducing inflammatory activity on MRI scans. The safety and tolerability profile of the biosimilar also was comparable to that of the name-brand medication.

Biosimilar natalizumab was developed by scientists at Polpharma Biologics and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz, a division of Novartis, has the rights to commercialise 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.

Michael Soldan, CEO