On 27 November 2025, Celltrion announced that it has launched Omlyclo®, the first biosimilar to Novartis’ Xolair® (omalizumab) in Brazil, Latin America’s largest pharmaceutical market.
Two days earlier, on 25 November 2025, Celltrion also announced the completion of its Omlyclo® launch in major European countries including Germany, Spain, the UK and France, and that it has successfully secured bids from multiple hospital groups in the Netherlands, securing 70% of the Dutch market.
Omlyclo® is the first and only omalizumab biosimilar to be approved in the EU, with Celltrion’s 75 mg/0.5 mL and 150 mg/1 mL PFS formulations receiving EU market authorisation in May 2024. Celltrion commenced its European rollout of Omlyco® with the launch of the product in Norway in September 2025. Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.
Aurobindo, Teva, Glenmark and Kashiv reportedly 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.