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CuraTeQ’s Trastuzumab Biosimilar UK Approved

Aug 26, 2025

On 26 August 2025, Medical Dialogues reported that Aurobindo Pharma subsidiary, CuraTeQ Biologics, has received marketing approval from the UK’s MHRA for Dazublys®, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), for the treatment of HER2-positive breast or gastric cancer.

In July 2025, Dazublys® was approved in the EU for the same indication following the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in April 2025.

Samsung Bioepis’ Ontruzant® was the first trastuzumab biosimilar to be approved in the EU (November 2017).  Other trastuzumab biosimilars since approved in the UK include Amgen’s Kanjinti® (May 2018), Pfizer’s Trazimera® (July 2018), Celltrion’s Herzuma® (January 2021), Biocon’s Ogivri® (January 2021) and Organon’s Ontruzant® (January 2021).