CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd., has obtained marketing authorisation from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Dazublys, its trastuzumab biosimilar version.
Earlier in July 2025, Dazublys has received the marketing authorisation in the European Union from the European Commission (EC). This is CuraTeQ’s fourth biosimilar to be approved by MHRA after the approval of Bevqolva in December 2024 and Zefylti in May 2025 and Dyrupeg in June 2025. Dazublys, Zefylti, and Dyrupeg are also approved in the European Union.
Dazublys is indicated for the treatment of HER2-positive breast and gastric cancers, offering a more accessible therapeutic option in oncology care. The biosimilar has shown comparable quality, safety, and efficacy to the original trastuzumab product
Earlier in April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for Dazublys, recommending its marketing authorization, according to a stock exchange filing.
