Aurobindo Pharma’s Dazublys Approval - Entering the ARV and Biosimilar market in a big way

Aurobindo Pharma has received marketing authorisation for its cancer treatment biosimilar, Dazublys , in Europe. The approval was granted by European authorities following a positive opinion from the European Medicines Agency (EMA) in April 2025. Dazublys is a trastuzumab biosimilar , used to treat HER2-positive breast and gastric cancers by targeting HER2 receptors on cancer cells. It is a biosimilar version of Herceptin , developed by Roche/Genentech. This marks Aurobindo's third biosimilar approved by the EMA , following approvals for Dyrupeg and Zefylti , both used in chemotherapy support. With a total of four EU and one UK approval , the company continues to strengthen its presence in the oncology and immunology segments through its wholly-owned subsidiary, CuraTeQ Biologics