On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.
Celltrion announced the Korean approval of the autoinjector presentation of Omlyclo®, biosimilar to Novartis’ Xolair®, in December 2025. The launch comes three months after Celltrion’s Korean launch of its high dose (300 mg) Omlyclo® formulation.
Celltrion’s Omlyclo® (CT-P39) is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® was approved in the US in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and in December 2025 (300mg formulation). Celltrion commenced its European rollout of Omlyclo® with the launch of the product 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, while in January 2026, high dose Omlyclo® (PFS and autoinjector) was approved in Canada.
Kashiv BioSciences/Alvotech are likely to be the next companies with an approved omalizumab biosimilar on the market. 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. An application for ADL-018 was accepted for review by Health Canada in June 2026 and marketing applications for AVT23 were accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025. Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).
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).