CuraTeQ Biologics, the wholly owned biosimilars arm of Aurobindo Pharma, has announced positive top-line Phase 3 results for BP11, its investigational biosimilar to Xolair (omalizumab), marking a major clinical milestone in the company’s global biologics strategy. 

The Phase 3 study enrolled 608 patients across nearly 80 sites in seven European countries and India, evaluating BP11 in chronic spontaneous urticaria (CSU) at the 300 mg dose. The trial successfully met all primary and co-primary endpoints, demonstrating strong equivalence and relative potency versus the reference product, with confidence intervals well within predefined regulatory margins. 

The positive data package is expected to support regulatory submissions for CSU, allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) in major markets, including the US and Europe. 

“This Phase 3 success reinforces CuraTeQ’s growing strength in high-value biosimilars and advances Aurobindo’s ambition to build a globally competitive biologics portfolio,” the development signals for the broader Indian biosimilars sector.

According to the company, it plans to complete filings with both the EMA and US FDA by the end of Q2 2026, positioning BP11 as a potential cost-effective alternative in a large and rapidly expanding immunology market. 

The development is particularly significant as omalizumab remains a high-value biologic therapy in allergy and immunology, and successful biosimilar entry could improve patient access through more affordable treatment options.