CuraTeQ Biologics, a wholly-owned step-down subsidiary of Aurobindo Pharma Limited, has received marketing authorisation from the European Commission (EC) for its trastuzumab biosimilar, Dazublys. This approval follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion in April 2025, recognising Dazublys as highly similar to the reference biologic, Herceptin.
Dazublys is indicated for the treatment of HER2-positive breast cancer and gastric cancer, two aggressive forms of cancer with limited treatment accessibility in many regions. The biosimilar has demonstrated comparable quality, safety, and efficacy to the original trastuzumab, offering patients and healthcare systems a more affordable yet effective treatment option across EU member states.
The approval of Dazublys marks the third EMA-approved biosimilar for CuraTeQ in 2025 alone, highlighting the company’s growing footprint in the biosimilars space. Earlier this year, CuraTeQ secured marketing authorisation for Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February. Additionally, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Bevqolva, a bevacizumab biosimilar, in December 2024, bringing the company’s total approvals in the EU and UK regions to four.
This regulatory milestone is part of Aurobindo Pharma’s long-term strategy to strengthen its biosimilars portfolio, especially in oncology and immunology. With Dazublys now approved, the company is a step closer to its ambitious goal of launching at least 10 biosimilars globally by 2030.
The European Commission’s endorsement further validates CuraTeQ’s R&D and manufacturing capabilities in the high-barrier biologics sector. As biosimilars gain prominence in global therapeutic landscapes, approvals like Dazublys are key to enhancing treatment access, reducing healthcare costs, and driving sustainable innovation in cancer care.