26-04-2025
Aurobindo Pharma subsidiary receives positive opinion for biosimilar Dazublys from EMA
By Aman Shukla Published on April 26, 2025, 09:57 IST
CuraTeQ Biologics s.r.o., a 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 for Dazublys® (150 mg powder for concentrate for solution for infusion). Dazublys® is a biosimilar to trastuzumab, developed for the treatment of HER2-positive metastatic and early breast cancers.
Trastuzumab, the active ingredient in Dazublys®, targets and inhibits the HER2 protein, which is over-expressed in certain cancers, particularly breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its signaling, leading to cell cycle arrest, reduced tumor growth, and activation of the immune system to attack cancer cells.
The positive CHMP opinion is an important step for Dazublys® towards securing marketing authorization in the European Union. This approval would provide healthcare professionals with an effective, cost-effective alternative for treating HER2-positive breast cancer, potentially improving access to vital cancer therapies.
CuraTeQ Biologics is committed to enhancing patient outcomes with biosimilar medicines, offering an affordable treatment option for cancer patients. The company remains focused on expanding its portfolio of biosimilars to address critical healthcare needs.
Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
