On 6 October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for AVT23, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).
AVT23 (also known as ADL-018) was developed by Alvotech in collaboration with Kashiv Biosciences and is the subject of an October 2023 licensing agreement under which Advanz Pharma has exclusive commercialisation rights for the European Economic Area (European Union, Norway, Iceland and Lichtenstein), the UK, Switzerland, Canada, Australia and New Zealand. A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.
Celltrion has already commenced the European launch of its omalizumab biosimilar, Omlyclo®, beginning in Norway in September 2025. Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). It has been the subject of patent infringement actions in at least the UK and Europe. Omalizumab biosimilars are also under development by Aurobindo, Teva and Glenmark.