On 6 April 2026, Aurobindo’s wholly owned subsidiary, CuraTeQ Biologics, announced it has obtained positive top-line results from a Phase 3 study of BP11 (omalizumab, 300 mg), biosimilar to Genentech/Novartis’ Xolair®.
According to CuraTeQ, the study, which was conducted in 608 patients across 80 sites in Europe and India, successfully met all primary endpoints, demonstrating comparable efficacy and safety to Xolair® in patients with chronic spontaneous urticaria at the 300 mg dose.
Buoyed by these results, which follow completion of a Phase 1 study in March 2024, CuraTeQ is planning to complete regulatory filings with both the European Medicines Agency and the FDA by the end of Q2 2026.
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar on the market anywhere in the world. Omlyclo® has been approved in: the EU (May 2024, with a high dose (300 mg) form approved November 2025); Korea (June 2024, as PFS, with autoinjector approved December 2025; high dose formulation launched 30 March 2026); Australia (November 2024); Canada (December 2024, with a high dose formulation approved January 2026); the US (March 2025, in 75 mg/0.5ml and 150 mg/ml PFS forms, with full interchangeable status, and December 2025 in high dose); New Zealand (April 2025); and Japan (March 2026). 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.
Biosimilar omalizumab is also under development. Teva announced in March 2026 that its regulatory applications for an omalizumab biosimilar have been accepted for review by the FDA and the European Medicines Agency for all approved reference indications. 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.