Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 06, 2026, titled "Press Release - CuraTeQ Biologics Announces Positive Top-Line Results for Phase 3 Study of Omalizumab Biosimilar BP11".
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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Aurobindo Pharma's wholly-owned subsidiary CuraTeQ Biologics announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar referencing Xolair (omalizumab). The trial enrolled 608 patients across approximately 80 sites in 7 European countries and India. The study met all primary endpoints, demonstrating high comparability to the reference product in patients with chronic spontaneous urticaria at the 300mg dose. Results showed precise equivalence with tight confidence intervals within predefined margins. The biosimilar also met co-primary potency criteria across dose levels. CuraTeQ plans to file for regulatory approval with both EMA and FDA by the end of Q2 2026, targeting indications including CSU, allergic asthma, and chronic rhinosinusitis with nasal polyps.
This positive Phase 3 readout is a significant milestone for Aurobindo's biosimilar pipeline, potentially opening a new revenue stream in the high-value biologics market. Successful approval would expand the company's product portfolio beyond traditional generics into complex biosimilars, which typically command higher margins.