CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has made significant strides in its biosimilar development pipeline. While there is no recent update on the completion of a Phase 1 study for a Denosumab biosimilar, CuraTeQ has successfully completed Phase 1 trials for its Omalizumab biosimilar, BP11. Additionally, the company has received positive opinions from the European Medicines Agency (EMA) for other biosimilars, highlighting its commitment to delivering high-quality, cost-effective treatments.
Key Highlights:
Omalizumab Biosimilar (BP11): CuraTeQ has completed Phase 1 trials for BP11, demonstrating pharmacokinetic and pharmacodynamic equivalence to the reference product Xolair. Phase 3 trials are underway for chronic spontaneous urticaria and asthma.
Denosumab Biosimilar: Although specific Phase 1 completion details are not available, Aurobindo Pharma has mentioned completing Phase 3 recruitment for its Denosumab biosimilar across 40 sites in Europe. The filing is expected between Q2 and Q3 of FY26.
Pipeline and Approvals: CuraTeQ has a robust pipeline of 14 biosimilars, with several products in Phase 3 trials. It recently received a positive opinion from the EMA for Dyrupeg, a pegylated filgrastim biosimilar.
Market Strategy: CuraTeQ aims to leverage its end-to-end capabilities to bring these biosimilars to global markets, enhancing access to affordable treatments for patients worldwide.
This strategic approach positions CuraTeQ Biologics as a key player in the biosimilars market, with a focus on improving patient outcomes through innovative and cost-effective solutions.
Source: The Times of India, Aurobindo Pharma Website, CuraTeQ Biologics Website