CuraTeQ Biologics, the wholly owned step-down subsidiary of Aurobindo Pharma Ltd, on 2 July introduced that it has obtained advertising authorisation from the European Fee for its trastuzumab biosimilar, Dazublys.
This approval follows the European Medicines Company’s (EMA) Committee for Medicinal Merchandise for Human Use (CHMP) issuing a optimistic opinion in April 2025, recommending Dazublys for approval based mostly on its confirmed similarity to the reference biologic, Herceptin.
Dazublys is indicated for treating HER2-positive breast and gastric cancers, offering a extra inexpensive therapy various in oncology. The biosimilar demonstrated equal high quality, security, and efficacy to trastuzumab, enabling its use throughout all EU member states.
In response to a inventory alternate submitting, “CuraTeQ Biologics… a subsidiary of Aurobindo Pharma Restricted, has obtained advertising authorisation from the European Fee for Dazublys… Earlier in April 2025, the European Medicines Company’s (EMA) Committee for Medicinal Merchandise for Human Use (CHMP) has adopted a optimistic opinion for Dazublys, recommending its advertising authorisation.”
This marks the third EMA-approved biosimilar for CuraTeQ in 2025, following approvals for Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February.
Moreover, CuraTeQ acquired approval for Bevqolva, its bevacizumab biosimilar, from the UK’s Medicines and Healthcare merchandise Regulatory Company (MHRA) in December 2024, bringing its whole biosimilar approvals within the EU area to 4.
The newest approval for Dazublys strengthens Aurobindo Pharma’s strategic push to develop its biosimilars pipeline, particularly in oncology and immunology, with plans to launch a minimum of 10 biosimilars globally by 2030.
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