CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, announced positive top-line results from its Phase 3 trial for its Omalizumab biosimilar, BP11.
The Phase 3 study in chronic spontaneous urticaria patients met all primary endpoints, showing comparability to the reference product.
The company plans to file for regulatory approval with the EMA and FDA by the end of Q2 2026.
The trial involved 608 patients across 80 sites in Europe and India, meeting its primary and co-primary endpoints.