
New Launch6 April 2026 at 10:35 am
Aurobindo Pharma's Subsidiary CuraTeQ Biologics Reports Positive Top-Line Results for Omalizumab Biosimilar BP11 Phase 3 Study
AI Summary
CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar to Xolair® (omalizumab). The study successfully met all primary endpoints, showing high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose. The trial was conducted in 608 patients across approximately 80 sites in seven European countries and India. The results support regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).
Key Highlights
- CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Ltd, announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar to Xolair® (omalizumab).
- The study successfully met all primary endpoints, showing high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose.
- The trial was conducted in 608 patients across approximately 80 sites in seven European countries and India.
- The results support regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).
- Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India, with a robust product portfolio spread over seven major therapeutic/product areas.
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