Hyderabad, April 6 (RAHNUMA): CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has announced positive top-line results from its Phase 3 trial of BP11, an investigational biosimilar to Omalizumab (marketed as Xolair).
The study met all primary endpoints, demonstrating strong comparability with the reference drug in treating chronic spontaneous urticaria (CSU) at a 300 mg dose. Conducted across 608 patients at nearly 80 sites in Europe and India, the trial showed precise equivalence in itch severity reduction at Week 12, aligning with requirements of both the Food and Drug Administration and European Medicines Agency.
The company said the results also confirmed comparable potency and consistent efficacy across dose levels, reinforcing BP11’s potential across multiple indications, including CSU, allergic asthma, and chronic rhinosinusitis with nasal polyps.
CuraTeQ plans to complete regulatory filings with the FDA and EMA by Q2 2026, aiming to expand access to cost-effective biologic therapies.
Dr Arpitkumar Prajapati, head of clinical development, said “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.”
Dr. Disha Dadke, head of R&D and regulatory sciences, said “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.”
