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Aurobindo Pharma Gets EU Nod for Dazublys Trastuzumab Biosimilar

Synopsis:

CuraTeQ Biologics, a step-down subsidiary of Aurobindo Pharma, has received marketing authorisation from the European Commission for Dazublys, its trastuzumab biosimilar. This approval follows a positive EMA opinion and supports treatment of HER2-positive breast and gastric cancers.


Aurobindo Pharma Ltd’s step-down subsidiary, CuraTeQ Biologics, has secured marketing authorisation from the European Commission for Dazublys, its trastuzumab biosimilar. The approval enables the company to market Dazublys across EU member states for treating HER2-positive breast and gastric cancers.

Also read: Nestle India Adds New Maggi Line at Sanand Plant with Rs. 105 Crore Capex

AUROBINDO PHARMA LTD

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1156.1-1.90 (-0.16 %)

Updated - 03 July 2025
1164.00day high
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1144.20day low
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971525
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Key takeaways

  • European Commission grants marketing authorisation for Dazublys

  • Dazublys is CuraTeQ’s third EMA-approved biosimilar in 2025

  • Indicated for HER2-positive breast and gastric cancers

  • EMA’s CHMP had issued a positive opinion in April 2025

  • Aurobindo aims to launch 10 biosimilars globally by 2030

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EMA support and therapeutic value

The EU clearance follows a favourable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which concluded that Dazublys matched the reference product Herceptin in quality, safety, and efficacy. Dazublys is designed to serve as a more affordable treatment option in oncology care across Europe.

This development marks CuraTeQ’s third biosimilar approval from the EMA in 2025. Earlier approvals include Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February. Additionally, the company secured approval for Bevqolva (bevacizumab biosimilar) from the UK’s MHRA in December 2024.

Approved biosimilars by CuraTeQ

Product Name

Molecule

Approval Body

Approval Date

Dazublys

Trastuzumab

EC

July 2025

Dyrupeg

Pegylated Filgrastim

EMA

April 2025

Zefylti

Filgrastim

EMA

February 2025

Bevqolva

Bevacizumab

MHRA (UK)

December 2024

Strategic growth in biosimilars

The latest authorisation further reinforces Aurobindo Pharma’s long-term strategy of expanding its biosimilars portfolio. The company is targeting at least 10 biosimilar launches by 2030, with a focus on oncology and immunology therapies. The EU approval of Dazublys opens up new revenue streams in regulated markets and positions CuraTeQ as a competitive biologics player.

Following the announcement, Aurobindo Pharma share price rose by 2.23% on the BSE to close at Rs. 1,157.75. This regulatory milestone is likely to keep investor attention on Aurobindo Pharma share price as the biosimilars segment continues to scale. Market watchers will also track how future authorisations affect Aurobindo Pharma share price amid rising global competition.

Also read: Indian Overseas Bank Gets Shareholder Nod to Raise Rs. 4,000 Crore

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