Posted by Michael Wonder on 24 Jul 2023
Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies in RRMS patients.
Sandoz today announced that the CHMP of the EMA, has adopted a positive opinion for marketing authorisation for first of a kind biosimilar natalizumab developed by Polpharma Biologics.
