India Pharma Outlook Team | Monday, 13 April 2026
CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has reported encouraging results from its Phase 3 clinical trial of BP11 biosimilar, a biosimilar to the widely used biologic drug Xolair (omalizumab). The announcement marks a key milestone in the company’s journey to expand access to affordable biologic treatments.
The late-stage trial involved over 600 patients across nearly 80 clinical sites in Europe and India. It focused on treating chronic spontaneous urticaria, a condition that causes recurring hives and severe itching. According to the company, BP11 met all primary and co-primary endpoints, showing strong similarity in effectiveness to the original drug and reinforcing its position in the biosimilars market.
One of the main measures in the study was the reduction in itch severity over a 12-week period. BP11 demonstrated results that closely matched those of Xolair, meeting the strict criteria required by global regulators such as the US Food and Drug Administration and the European Medicines Agency. This confirms strong alignment with global regulatory approvals standards.
The study also confirmed consistent dose response and comparable safety outcomes, with no meaningful differences observed between BP11 and the original therapy. These findings strengthen confidence in clinical trial results and the product’s reliability as a biologic therapy alternative.
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With these positive results, CuraTeQ is preparing to file for approvals in key markets, including the United States and Europe, by mid-2026. The biosimilar is being developed for multiple conditions beyond CSU, such as allergic asthma treatment and chronic rhinosinusitis with nasal polyps.
Company officials said the results highlight their focus on delivering high-quality, cost-effective solutions. As healthcare systems worldwide look for ways to reduce costs, biosimilars like BP11 are expected to play an increasing role in improving patient access to medicines.
CuraTeQ’s progress reflects its growing strength in biologics development and its commitment to expanding global healthcare access through innovation and affordability.
