Aurobindo’s Dazublys Gets EU Green Light: Biosimilar Set to Transform HER2+ Cancer Care

Aurobindo Pharma has secured a major regulatory milestone with the European Commission granting marketing approval for Dazublys, its trastuzumab biosimilar, developed by subsidiary CuraTeQ Biologics. The approval follows a positive opinion from the European Medicines Agency’s CHMP in April and marks Aurobindo’s third biosimilar to receive EU clearance.

 

Dazublys is indicated for the treatment of HER2-positive metastatic and early breast cancer, as well as metastatic gastric cancer. It is a biosimilar to Roche’s blockbuster drug Herceptin, offering a cost-effective alternative with comparable efficacy and safety.

 

Key Highlights:

 

Product Profile: Dazublys is a 150 mg powder for infusion, targeting HER2 receptors to inhibit tumor growth.

Therapeutic Scope: Approved for HER2+ metastatic and early breast cancer, and HER2+ gastric cancer.

Strategic Milestone: Marks Aurobindo’s third biosimilar approval in the EU and fourth overall in Europe.

Market Impact: Expected to improve access to affordable oncology treatments across EU member states.

Pipeline Momentum: CuraTeQ aims to launch 10 biosimilars by 2030, focusing on oncology and immunology.

CEO Insight: Dr. Satakarni Makkapati emphasized the approval as a validation of CuraTeQ’s end-to-end biologics capabilities and commitment to global cancer care.

 

With Dazublys now cleared for European markets, Aurobindo strengthens its foothold in the high-growth biosimilars segment, reinforcing its ambition to become a global leader in affordable biologics.

 

Sources: European Medicines Agency, CuraTeQ Biologics, Business Upturn