On 4 August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, and was first approved in pre-filled syringe (PFS) presentations in November 2024, which were listed on the Pharmaceutical Benefits Scheme (PBS) on 1 August 2025.
Omlyclo® is also approved in the EU (May 2024), Korea (June 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). It has been the subject of legal disputes in at least the UK and Europe.
Kashiv Biosciences/Alvotech had a marketing application for omalizumab biosimilar AVT32 accepted in the UK in March 2025, while other companies, including Aurobindo, Teva and Glenmark, reportedly have omalizumab biosimilars under development.