EMA accepts first-ever MAA for Tysabri biosimilar

Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri.

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).1

Blockbuster drug Tysabri was developed and is marketed by US biotech major Biogen (Nasdaq: BIIB), and recorded first-quarter 2022 sales of $520.8 million, up 3.5% year-on-year, for the company.