CuraTeQ Biologics, the wholly owned step-down subsidiary of Aurobindo Pharma Ltd, on 2 July announced that it has obtained marketing authorisation from the European Commission 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, recommending Dazublys for approval based on its proven similarity to the reference biologic, Herceptin.

Dazublys is indicated for treating HER2-positive breast and gastric cancers, providing a more affordable treatment alternative in oncology. The biosimilar demonstrated equivalent quality, safety, and efficacy to trastuzumab, enabling its use across all EU member states.

According to a stock exchange filing, “CuraTeQ Biologics… a subsidiary of Aurobindo Pharma Limited, has obtained marketing authorisation from the European Commission for Dazublys… Earlier in April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dazublys, recommending its marketing 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.

Additionally, CuraTeQ received approval for Bevqolva, its bevacizumab biosimilar, from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2024, bringing its total biosimilar approvals in the EU region to four.

The latest approval for Dazublys strengthens Aurobindo Pharma’s strategic push to expand its biosimilars pipeline, especially in oncology and immunology, with plans to launch at least 10 biosimilars globally by 2030.

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