Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, a proposed biosimilar to Tysabri.
The application is for an intravenous route of administration, with the same dosing regimen, presentation and indication as the reference medicine Tysabri - a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis.
