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CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received a positive opinion from the CHMP for its trastuzumab biosimilar, Dazublys®, aimed at treating HER2-positive metastatic and early breast cancers. This endorsement highlights the comprehensive analytical similarity between Dazublys® and the reference product, Herceptin®, in terms of critical parameters such as pharmacokinetics and safety.
The anticipated approval from the European Commission in July will enable Dazublys® to be available across EU member states. This latest achievement marks Aurobindo's commitment to expanding its biosimilars portfolio, as the company aims to launch at least 10 additional biosimilars by 2030. Aurobindo's Vice Chairman emphasized this positive news as a reflection of their focus on biosimilars as a core business area, which is essential in providing cost-effective therapies for cancer treatment.