CuraTeQ Biologics announces Positive Top-Line Results for Phase 3 Study of Omalizumab Biosimilar BP11

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd and a biopharmaceutical company developing biosimilars, today 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, evaluating change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, the main primary endpoint applicable for both FDA and EMA approvals. Results demonstrated precise equivalence, with tight confidence intervals well within the predefined margins (-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. These outcomes reflect well-contained variability, robustness of data, and strong efficacy alignment. The results support regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).

"These Phase 3 results with narrow confidence intervals validate our clinical strategy and the team's execution in delivering a high-quality biosimilar. Detailed results will be submitted for regulatory review and presented at upcoming medical conferences," said Dr. Arpitkumar Prajapati, Head of Clinical Development.

"BP11 demonstrates comparable efficacy and safety to Xolair, paving the way for patient access to affordable treatment options. We are planning to complete filing of BP11 with both EMA and FDA by the end of Q2 2026," said Dr. Disha Dadke, Head of R&D and Regulatory Sciences.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1339.80 as compared to the previous close of Rs. 1335.95. The total number of shares traded during the day was 62609 in over 7623 trades.

The stock hit an intraday high of Rs. 1356.00 and intraday low of 1318.25. The net turnover during the day was Rs. 83455251.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 Pharmaceuticals CuraTeQBiologics Phase3Study Omalizumba BP11 Biosimilar