Aurobindo Pharma arm CuraTeQ Biologics gets positive opinion for breast cancer drug Dazublys from EMA

Hyderabad: CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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.

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.

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."

Aurobindo Pharma’s Vice Chairman and Managing Director Mr. Nithyananda Reddy said, "The CHMP’s positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies."