Aurobindo Pharma unit gets EU nod for Dazublys

Aurobindo Pharma announced today that its step-down subsidiary, CuraTeQ Biologics s.r.o., has received marketing authorization from the European Commission for its trastuzumab biosimilar Dazublys™. This marks CuraTeQ's third biosimilar approval from the European Medicines Agency (EMA) after Dyrupeg™ and Zefylti™, and the fourth overall in the EU, alongside the approval of Bevqolva™ by the UK's MHRA in December 2024. The EMA’s Committee for Medicinal Products for Human Use (CHMP) had previously adopted a positive opinion for Dazublys™ in April 2025. This approval signifies a significant step for Aurobindo Pharma in expanding its biosimilar portfolio in the European market.