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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.
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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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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.
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 |
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.
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