Dazublys approved for cancer

CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

Commenting on the update, Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO Biologics, Vaccines, and Peptides stated “The CHMP’s positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys and the reference biologic product Herceptin in terms of pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys will be available for use across EU member states. This marks our third biosimilar to receive CHMP’s endorsement and the fourth overall in the EU, alongside the approval of Bevqolva (a bevacizumab biosimilar) by the MHRA in November 2024. Biosimilars are playing an important role in improving cancer care, and we remain committed to expanding our biosimilars portfolio to address the unmet needs of patients.”

Dazublys will be available as a 150 mg powder for concentrate for solution for infusion.