Aurobindo Pharma’s subsidiary, CuraTeQ Biologics, has announced successful top-line results from its Phase 3 clinical study of BP11, a biosimilar to Xolair (omalizumab). The study met all primary endpoints, demonstrating high comparability in safety and efficacy for patients with chronic spontaneous urticaria (CSU). The company is now preparing for regulatory filings with the FDA and EMA, targeting completion by the end of Q2 2026.
Successful Clinical Trial Outcome
The Phase 3 study of BP11 involved 608 patients across approximately 80 clinical sites in India and seven European countries. The trial successfully met its primary endpoints, including the evaluation of the 7-point Itch Severity Score (ISS7) at Week 12. Results showed precise equivalence with the reference product, Xolair, with confidence intervals falling well within the required regulatory margins.
Strategic Regulatory Milestones
According to the company, the data confirms the robustness of the BP11 biosimilar, showing clear parallelism with the reference product across dose levels. This success provides a strong foundation for regulatory submissions covering multiple indications, including CSU, allergic asthma, and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The management team expects to finalize and submit filings to both the US FDA and European Medicines Agency (EMA) before the close of Q2 2026.
Commitment to Affordable Access
This development marks a significant step in Aurobindo Pharma’s strategy to expand its biosimilars portfolio. By providing a high-quality, comparable alternative to existing therapies, the company aims to improve patient access to affordable treatment options globally. Detailed results from the study are slated to be presented at forthcoming medical conferences and provided to regulatory authorities for official review.
Source: BSE
