CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma, obtained positive top-line results from phase 3 study of an investigational biosimilar to Xolair (omalizumab).
The study of the drug candidate (BP11) ‘successfully’ met all primary endpoints, showing high comparability to the reference product in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose.
“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,” Arpitkumar Prajapati, Head, Clinical Development, CuraTeQ Biologics said in a release on Monday.
BP11 Applications
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.’’
The trial was conducted in 608 patients across approximately 80 sites in seven European countries and India, evaluating change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, the main primary endpoint applicable for both FDA and EMA approvals. Results demonstrated precise equivalence, with tight confidence intervals well within the predefined margins.
The results support regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).