Aurobindo Pharma's subsidiary CuraTeQ Biologics Secures MHRA Approval for Trastuzumab Biosimilar Dazublys in HER2-Positive Cancer
Hyderabad: CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd., has secured marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for Dazublys, its trastuzumab biosimilar.
This approval follows the earlier marketing authorisation in the European Union by the European Commission in July 2025. Dazublys marks CuraTeQ’s fourth biosimilar to receive MHRA approval, after Bevqolva in December 2024, Zefylti in May 2025, and Dyrupeg in June 2025.
Notably, Dazublys, Zefylti, and Dyrupeg are also cleared for sale in the European Union.
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Dazublys is a biosimilar version of trastuzumab, used for the treatment of HER2-positive breast cancer and certain types of gastric cancer. It works by targeting the HER2 receptor on cancer cells, helping to slow or stop their growth.
The present approval strengthens CuraTeQ’s oncology portfolio and reinforces its presence in regulated markets.
Headquartered in Hyderabad, India, Aurobindo Pharma Ltd. is a leading global pharmaceutical company with operations spanning active pharmaceutical ingredients (APIs), generics, and biosimilars. CuraTeQ Biologics is its wholly owned subsidiary focused on biosimilars for oncology and other therapeutic areas, enhancing Aurobindo’s footprint in biologics markets in Europe and beyond.
