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

CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys® (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.

Commenting on the update, Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO Biologics, Vaccines, and Peptides stated “The CHMP’s positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys® and the reference biologic product Herceptin in terms of pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys® will be available for use across EU member states. This marks our third biosimilar to receive CHMP’s endorsement and the fourth overall in the EU, alongside the approval of Bevqolva® (a bevacizumab biosimilar) by the MHRA in November 2024. Biosimilars are playing an important role in improving cancer care, and we remain committed to expanding our biosimilars portfolio to address the unmet needs of patients.”

Aurobindo Pharma’s Vice Chairman and Managing Director Mr. Nithyananda Reddy said, “The CHMP’s positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts inbuilding biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies.”

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: Medical Dialogues