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Biosimilar Shows Strong Phase 3 Results
6 Apr
Summary
- BP11, a biosimilar to Xolair, demonstrated high comparability.
- Phase 3 study met all primary endpoints for chronic spontaneous urticaria.
- Regulatory submissions planned for US and European drug regulators.
CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has reported positive top-line Phase 3 results for BP11, an investigational biosimilar to Xolair. The study successfully met all primary endpoints in patients with chronic spontaneous urticaria who received a 300 mg dose, demonstrating strong comparability to the reference product.
These findings are crucial for supporting regulatory submissions to the US and European drug regulators for indications including chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps. The Phase 3 trial involved 608 patients across approximately 80 sites in seven European countries and India. The primary endpoint, measuring the change from baseline in the Itch Severity Score at Week 12, was met, falling within the predefined confidence intervals.
Further analysis of a co-primary endpoint assessing relative potency also met its criteria, indicating parallelism between BP11 and Xolair. This suggests controlled variability and aligned efficacy. CuraTeQ Biologics plans to complete filings with the EMA and FDA by the end of Q2 2026, aiming to provide patients with access to more affordable treatment options.
