Aurobindo Pharma’s Subsidiary Reports Phase 3 Success for Biosimilar

Aurobindo Pharma Ltd, through its wholly owned subsidiary CuraTeQ Biologics Private Limited, has announced positive top-line results from a Phase 3 study of BP11, an investigational biosimilar to Xolair® (omalizumab). The study successfully met all primary endpoints, demonstrating high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose. The trial was conducted with 608 patients across approximately 80 sites in seven European countries and India.

The financial terms related to the development and potential commercialization of BP11 were not disclosed in the filing. However, the successful completion of the Phase 3 trial is a critical step towards regulatory submissions and potential market entry. The results are expected to facilitate filings with both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) by the end of the second quarter of 2026.

The scope of the Phase 3 trial included evaluating the change from baseline in the 7-point Itch Severity Score (ISS7) at Week 12, which is the main primary endpoint applicable for both FDA and EMA approvals. The results demonstrated precise equivalence with tight confidence intervals well within the predefined margins of -2.5 to 2.0. The co-primary endpoint of relative potency, based on change from baseline in ISS7 at Week 12 using a 4-point assay, also met its criteria, demonstrating parallelism between BP11 and Xolair across dose levels.

The trial’s outcomes support regulatory submissions targeting CSU, allergic asthma, and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). These results reflect well-contained variability and robustness of data, indicating strong efficacy alignment. The detailed results will be submitted for regulatory review and presented at upcoming medical conferences.

The timeline for the regulatory submission is set for completion by the end of the second quarter of 2026. The trial involved multiple sites across Europe and India, highlighting the global scope of the study. The successful completion of this trial marks a significant milestone in the development of BP11 as a biosimilar to Xolair.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. Aurobindo Pharma operates over 30 manufacturing and packaging facilities approved by leading regulatory agencies, emphasizing its commitment to expanding its biosimilar portfolio.