On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg pre-filled syringe (PFS) and autoinjector (AI) formulations. Celltrion now has Canadian approved PFS and AI formulations of Omlyclo® in all strengths of Canadian approved Xolair® (75mg, 150mg and 300mg).
Omlyclo® was the first omalizumab biosimilar approved in Canada in December 2024 and remains the only Canadian approved biosimilar omalizumab to date.
The approval of the high dose formulations of Omlyclo® in Canada follows approvals of a PFS presentation of the 300mg dosage form in the US, in December 2025, and in the EU, in November 2025.
Aurobindo, Teva, Glenmark and Kashiv also have omalizumab biosimilars under development. On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.