Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed biosimilar to Xolair (omalizumab).
Alvotech developed AVT23 in collaboration with Kashiv BioSciences and Advanz Pharma has licensed commercial rights in the European Economic Area (European Union, Norway, Iceland and Lichtenstein), UK, Switzerland, Canada, Australia and New Zealand. The UK MHRA accepted a Marketing Authorization Application for AVT23 earlier this year.
