Aurobindo Pharma’s wholly owned subsidiary, CuraTeQ Biologics, has reported positive top-line results from the Phase 3 trial of its omalizumab biosimilar, BP11, indicating comparable efficacy and safety to the reference drug, Xolair.
An omalizumab biosimilar is a biologic similar to the branded drug Xolair, developed after patent expiry. Omalizumab is a monoclonal antibody that targets IgE, reducing allergic responses by blocking inflammatory pathways. It is used to treat moderate-to-severe allergic asthma, chronic spontaneous urticaria, and other IgE-mediated conditions.
As per Aurobindo Pharma’s exchange filing, the study met all primary endpoints in patients with chronic spontaneous urticaria (CSU) at the 300 mg dose. It evaluated changes in ISS7 (7-point Itch Severity Score) at Week 12, a key endpoint considered for regulatory approvals in the US and Europe.
The trial was conducted on 608 patients across nearly 80 sites in Europe and India. The results showed equivalence between BP11 and Xolair, with confidence intervals within the predefined margins.
Secondary endpoints, including relative potency based on ISS7 changes, also met the required criteria, indicating a similar dose response.
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“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,” said Dr Arpitkumar Prajapati, Head of Clinical Development.
“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,” said Dr Disha Dadke, Head of R&D and Regulatory Sciences.
The company plans to seek approvals for BP11 in multiple indications, including CSU, allergic asthma, and chronic rhinosinusitis with nasal polyps.
Shares of Aurobindo Pharma ended today’s trade 0.5% higher at ₹1,340.2 on the NSE.
