CuraTeQ Biologics achieves milestone in Omalizumab biosimilar development
CuraTeQ Biologics Private Limited, a fully integrated arm of Aurobindo Pharma Ltd, has announced significant progress in its biosimilar program, revealing that its Omalizumab biosimilar candidate, BP11, has successfully met the primary endpoints in a Phase 1 trial. The study, engaging 165 healthy volunteers across Australia and New Zealand, was designed to compare BP11 with the EU and US-sourced reference product, Xolair, in terms of pharmacokinetics (PK) and pharmacodynamics (PD).
The trial’s primary goal was to establish PK equivalence between BP11 and the Omalizumab products licensed in the US and EU. Volunteers were randomized to receive either BP11 or the EU/US versions of Omalizumab through subcutaneous injections. The findings confirmed that both the maximum serum concentration (Cmax) and the area under the concentration-time curve (AUC0-inf) for BP11 fell within the 80-125% range required for bioequivalence. Additionally, BP11 matched the IgE levels observed with Xolair, showcasing a comparable pharmacodynamic profile. Safety and immunogenicity aspects of BP11 were also found to be in line with the original Xolair product.
Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, highlighted the trial’s success, stating, “Results of both primary parameters, i.e., maximum serum concentration (Cmax) and area under concentration-time curve from time zero to infinity (AUC0-inf), were contained within 80-125% bioequivalence limit demonstrating PK equivalence between BP11 and both US and EU sourced Xolair.”
Dr. Disha Dadke, Associate President and Head of R&D at CuraTeQ, shared future plans: “We have initiated a Phase 3 study of our Omalizumab candidate BP11 for the treatment of chronic spontaneous or idiopathic urticaria… Additionally, a separate Phase 3 trial in asthma patients is being carried out in the Indian population.”
Following the successful Phase 1 outcomes, CuraTeQ has embarked on Phase 3 studies targeting chronic spontaneous urticaria, with a 600-patient trial across seven European countries. Another Phase 3 trial focuses on asthma patients within India. With these studies, CuraTeQ aims to file for regulatory approval of the BP11 biosimilar in India by 2024 and in other regulated markets by 2025.
CuraTeQ Biologics’ advancement into Phase 3 trials for its Omalizumab biosimilar, BP11, marks a critical step in providing accessible treatment options for chronic spontaneous urticaria and asthma patients. By demonstrating bioequivalence to Xolair, CuraTeQ positions itself as a key player in the biosimilar market, contributing to the broader availability of essential medicines.
The progress CuraTeQ Biologics has made in developing the Omalizumab biosimilar is commendable. Successfully meeting Phase 1 trial endpoints signifies not only the potential of BP11 to provide a clinically equivalent alternative to Xolair but also underscores the importance of biosimilars in the pharmaceutical landscape. Phase 3 trials will be instrumental in further validating BP11’s efficacy and safety, paving the way for regulatory approvals and eventual market entry.