Aurobindo Pharma’s Dazublys Receives EU Approval for HER2-Positive Cancers

Aurobindo Pharma has secured European Commission marketing authorisation for Dazublys, a biosimilar to trastuzumab, developed by its subsidiary CuraTeQ Biologics. This approval follows the European Medicines Agency’s CHMP positive opinion in April 2025, confirming Dazublys’ comparable quality, safety, and efficacy to Herceptin. 

Dazublys is indicated for HER2-positive metastatic and early breast cancers, as well as metastatic gastric cancer. It will be available as a 150 mg powder for infusion across EU member states. 

This marks CuraTeQ’s third EMA-approved biosimilar, following Dyrupeg and Zefylti, and the fourth overall in the EU, including Bevqolva approved by the UK’s MHRA. Aurobindo aims to launch at least 10 biosimilars across oncology and immunology by 2030.