CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has announced positive top-line results from its Phase 3 clinical study of BP11, an investigational biosimilar to Xolair® (omalizumab). The study successfully met all primary and co-primary endpoints, demonstrating strong comparability with the reference product in patients diagnosed with chronic spontaneous urticaria (CSU).
The randomized, multi-center trial enrolled 608 patients across approximately 80 clinical sites spanning seven European countries and India. The primary endpoint evaluated the change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, a key regulatory measure for both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Results confirmed precise equivalence between BP11 and the reference product, with confidence intervals well within predefined margins.
In addition, the co-primary endpoint assessing relative potency using a four-point assay also met its criteria, demonstrating consistent dose-response relationships and parallelism across treatment groups. The findings indicate robust data quality, low variability, and strong alignment in efficacy and safety profiles between BP11 and the originator biologic.
The results support planned regulatory submissions for multiple indications, including chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP). The company expects to complete filings with both the FDA and EMA by the second quarter of 2026.
CuraTeQ Biologics continues to expand its biosimilar portfolio, focusing on improving global access to high-quality and cost-effective biologic therapies. The successful completion of this Phase 3 study marks a significant milestone in the company’s clinical development efforts and reinforces its capabilities in complex biologics.
Aurobindo Pharma, headquartered in Hyderabad, is a global pharmaceutical company with operations in over 150 countries. The company develops, manufactures, and markets a broad range of generic and specialty pharmaceuticals, supported by more than 30 manufacturing and packaging facilities approved by leading international regulatory authorities.
