Aurobindo Arm CuraTeQ Reports Positive Phase 3 Results for Xolair Biosimilar BP11
New Delhi: 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 Phase 3 study successfully met all primary endpoints, demonstrating high comparability with the reference product in patients suffering from chronic spontaneous urticaria (CSU) at the 300 mg dose.
The trial involved 608 patients across nearly 80 clinical sites spanning seven European countries and India. The primary endpoint evaluated was the change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, a key parameter for both USFDA and EMA approvals. The results showed precise equivalence, with confidence intervals well within the predefined margins of -2.5 to 2.0.
Additionally, the co-primary endpoint assessing relative potency—based on changes in ISS7 using a 4-point assay—was also successfully achieved. The findings demonstrated parallelism between BP11 and the reference product Xolair across different dose levels, indicating strong efficacy alignment and robust data consistency.
Based on these outcomes, CuraTeQ stated that the data supports future regulatory submissions for multiple indications, including chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).
Commenting on the development, Dr. Arpitkumar Prajapati, Head of Clinical Development, said that the Phase 3 results with narrow confidence intervals validate the company’s clinical strategy and execution. He added that detailed results will be submitted for regulatory review and presented at upcoming medical conferences.
Dr Disha Dadke, Head of R&D and Regulatory Sciences, noted that BP11 has demonstrated comparable efficacy and safety to Xolair, potentially improving access to more affordable treatment options. She further stated that the company plans to complete regulatory filings with both the USFDA and EMA by the end of Q2 2026.
Aurobindo Pharma Limited, headquartered in Hyderabad, is a global pharmaceutical company operating in over 150 countries. It manufactures and markets a wide range of generic pharmaceuticals, specialty products, and active pharmaceutical ingredients, supported by a strong research and development infrastructure.
