CuraTeQ Biologics Announces Positive Top-Line Results for Omalizumab Biosimilar BP11 Phase 3 Study

CuraTeQ Biologics Announces Positive Top-Line Results for Omalizumab Biosimilar BP11 Phase 3 Study​

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd and a biopharmaceutical company focusing on biosimilars, has announced positive top-line results from its Phase 3 study of BP11. BP11 is an investigational biosimilar to Xolair® (omalizumab).

The study successfully met all primary endpoints, demonstrating high comparability to the reference product in patients diagnosed with chronic spontaneous urticaria (CSU) at the 300 mg dose.

Trial Details and Efficacy Findings​

The Phase 3 trial was conducted involving 608 patients across approximately 80 sites spanning seven European countries and India. The primary endpoint evaluated was the change from baseline in the ISS7 (7-point Itch Severity Score) at Week 12, which is considered the main primary endpoint for both FDA and EMA approvals.

The results showed precise equivalence, with tight confidence intervals falling within the predefined margins of -2.5 to 2.0. Furthermore, the co-primary endpoint, relative potency based on change from baseline in ISS7 at Week 12 using a 4-point assay, also met its established criteria. This demonstrated parallelism between BP11 and Xolair across different dose levels, reflecting robust data and strong efficacy alignment.

These outcomes support regulatory submissions targeting CSU, allergic asthma, and CRSwNP (Chronic Rhinosinusitis with Nasal Polyps).

During the announcement, Dr. Arpitkumar Prajapati, Head of Clinical Development, stated that these Phase 3 results with narrow confidence intervals validate the company's clinical strategy and the team's execution in delivering a high-quality biosimilar.

Dr. Disha Dadke, Head of R&D and Regulatory Sciences, added that BP11 demonstrates comparable efficacy and safety to Xolair, positioning it to improve patient access to affordable treatment options. She mentioned plans to complete the filing of BP11 with both EMA and FDA by the end of Q2 2026.

Company Overview​

Aurobindo Pharma Limited, headquartered in Hyderabad, India, is an integrated global pharmaceutical company. The firm develops, manufactures, and commercializes a wide array of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients in over 150 countries.

Aurobindo Pharma Limited maintains over 30 manufacturing and packaging facilities, which are approved by major regulatory bodies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company's product portfolio spans seven major therapeutic areas: CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics, and Anti-Allergic.

For reference, Aurobindo Pharma Limited has the following identifiers:

AUROPHARMA Stock Price Movement​

At the close of trade, shares of Aurobindo Pharma Limited are edging higher by 0.49% to settle at ₹1340.2. The stock showed robust buying today, flirting with its highest level of the year with the intraday high hitting ₹1357.9, and seeing significant activity with over 1.5 million shares traded.

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