On 11 September 2026, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved in Australia in a 300 mg/2 mL solution for injection in pre-filled pen (PFP) and pre-filled syringe (PFS) forms.
The Australian approval follows launch of the 300 mg formulation of Omlyclo® in Europe (August 2026) and Korea (March 2026) and its approval in a number of other countries including the US (December 2025) and Canada (January 2026).
Omlyclo® is the only biosimilar omalizumab to have been approved in Australia, with the 75 mg/ 0.5 mL and 150 mg/1 mL PFS PBS-listed on 1 August 2025 and launched in Australia in September 2025, and the 75 mg/ 0.5 mL and 150 mg/1 mL PFP TGA-approved in August 2025 and recommended for PBS listing in April 2026.
Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025. Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand. Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).
Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026. Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.