On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab). According to Celltrion, the additional strength of Omlyclo® “can significantly decrease the frequency of injections and reduce injection burden and discomfort without compromising efficacy and safety”.
Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024.
Celltrion commenced its European rollout of Omlyco® with the launch of the product 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).
Omalizumab biosimilars are also under development by Alvotech/Kashiv, Aurobindo, Teva and Glenmark. In October 2025, Alvotech announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for its omalizumab biosimilar, AVT23.