Aurobindo Pharma Ltd’s wholly-owned step-down subsidiary, CuraTeQ Biologics, has received marketing authorisation from the European Commission for its trastuzumab biosimilar, Dazublys.

This regulatory milestone follows the positive opinion issued in April 2025 by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended Dazublys for approval based on its demonstrated similarity to the reference biologic, Herceptin.

Dazublys is indicated for the treatment of HER2-positive breast and gastric cancers, offering a more accessible therapeutic option in oncology care. The biosimilar has shown comparable quality, safety, and efficacy to the original trastuzumab product, supporting its use across EU member states.

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 authorization, according to a stock exchange filing.

This marks CuraTeQ’s third EMA-approved biosimilar in 2025, following the green light for Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February.

Additionally, Bevqolva, a bevacizumab biosimilar, was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2024, bringing CuraTeQ’s total EU-region biosimilar approvals to four.

The approval of Dazublys reinforces Aurobindo Pharma’s strategic focus on expanding its biosimilars portfolio, particularly in the oncology and immunology segments, with a goal of launching at least 10 biosimilars by 2030.

About CuraTeQ: CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.

Article excerpt reposted from: CNBC TV 18