On 30 March 2026, Celltrion announced that it launched its high dose (300 mg) Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in Korea, as reported by Korea Biomedical Review.
The Korean launch follows the January 2026 Canadian approval of high dose Omlyclo® (PFS and autoinjector) and approvals of a PFS presentation of the 300 mg dosage form in the US in December 2025 and EU in November 2025.
Celltrion is actively marketing Omlyclo® around the world, with a “launch event” held in Brazil on 31 March 2026, at which Celltrion and “key opinion leaders” presented clinical data, global prescribing experience and “value for use in clinical settings” in relation to the biosimilar. Omlyclo® was launched in Brazil in November 2025 and secured a state government tender in Santa Catarina.
While Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world, at least Aurobindo, Teva, Glenmark and Kashiv 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.