On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®. The trials were conducted on 165 healthy adults in Australia and New Zealand.
CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients. CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.
Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development. Celltrion submitted an A-BLA in the US earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.