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Aurobindo Pharma arm CuraTeQ reports omalizumab biosimilar candidate BP11 meets phase 1 trial endpoints

CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Ltd, announced that their omalizumab biosimilar candidate BP11 met phase 1 trial endpoints compared to the reference product Xolair from the EU and US. The PK/PD trial involved 165 healthy volunteers in Australia and New Zealand.

The primary aim was to establish pharmacokinetic (PK) equivalence between BP11 and Xolair from the US and EU. Volunteers received BP11 or EU/US licensed omalizumab subcutaneously. Results for primary parameters, maximum serum concentration (Cmax) and area under the concentration-time curve (AUC0-inf), fell within the 80-125% bioequivalence limit, indicating PK equivalence between BP11 and both Xolair sources.

BP11 exhibited similar IgE levels to Xolair, showcasing a comparable pharmacodynamic profile. Safety and immunogenicity profiles were comparable to the originator's product.

Aurobindo Pharma Limited, headquartered in Hyderabad, India, is a global pharmaceutical company involved in developing, manufacturing, and commercializing generic pharmaceuticals, branded speciality pharmaceuticals, and active pharmaceutical ingredients across 150+ countries.