Posted by Michael Wonder on 05 Nov 2024
European Medicines Agency confirms acceptance of marketing authorisation application for AVT05, a proposed biosimilar to Simponi (golimumab)
4 November 2024 - Alvotech and Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT05, Alvotech’s proposed biosimilar to Simponi (golimumab), a biologic used to treat several chronic inflammatory diseases.
This is believed to be the first marketing authorisation application filing announced globally for a biosimilar candidate to Simponi.
