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

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."