On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).
Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.
The Canadian filing follows a series of regulatory advances for ADL-018. Marketing applications for ADL-018 were accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March 2025 and by the European Medicines Agency (EMA) in October 2025.
Beyond Canada, Kashiv has agreements for the commercialisation of ADL-018 with Brazilian pharmaceutical company, CRISTÁLIA, for the Latin American market (11 August 2025) and MS Pharma for MENA markets (August 2025).
The only omalizumab biosimilar currently approved in Canada, and anywhere else in the world, is Celltrion’s Omlyclo®. Omlyclo® was approved in Canada in 75mg and 150mg formulations in December 2024 and in 300mg PFS and autoinjector presentations in January 2026.
Omlyclo® has also been approved in: the EU (May 2024 and November 2025 (300mg)); Korea (June 2024 (PFS), December 2025 (autoinjector), 300mg formulation launched 30 March 2026)); Australia (November 2024); the US (March 2025 (75 mg/0.5ml and 150 mg/ml PFS) and December 2025 (300mg)); New Zealand (April 2025); and Japan (March 2026). Celltrion commenced its European rollout of Omlyclo® in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025. In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.
Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).