On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway. The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.
On the same date, Celltrion also announced results from its global Phase 3 clinical trial of Omlyclo®, involving 619 patients with chronic spontaneous urticaria. Starting from week 12, patients who received Omlyclo® were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomised in a 1:1 ratio to either switch to Omlyclo® or to continue receiving the reference product. The results demonstrated comparable efficacy and safety to the reference product.
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.