CuraTeQ Biologics Secures UK Approval for Dazublys, Expanding Oncology Portfolio
Pharm'Up 
In a significant regulatory milestone, CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Ltd., has been granted marketing authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its trastuzumab biosimilar, Dazublys. This approval allows CuraTeQ to market the drug in the United Kingdom, strengthening its presence in the highly regulated European market.
The approval of Dazublys is particularly noteworthy as it comes shortly after the biosimilar received marketing authorization from the European Commission (EC) in July 2025. This dual approval in both the UK and the EU significantly broadens the potential patient access to this critical cancer therapy.
A Growing Portfolio of Biosimilars
Dazublys is indicated for the treatment of HER2-positive breast and gastric cancers, offering a more accessible and cost-effective therapeutic option for patients. The biosimilar has demonstrated comparable quality, safety, and efficacy to the reference trastuzumab product, providing clinicians with a trusted alternative.
This is the fourth biosimilar from CuraTeQ to receive MHRA approval, highlighting the company’s consistent progress in the biosimilar space. The previous approvals include:
- Bevqolva™ (a bevacizumab biosimilar) in December 2024
- Zefylti™ (a filgrastim biosimilar) in May 2025
- Dyrupeg™ (a pegfilgrastim biosimilar) in June 2025
Notably, Dazublys, Zefylti, and Dyrupeg are also approved in the European Union, underscoring the company’s successful strategy of targeting major international markets.
Strategic Vision and Future Outlook
The MHRA’s decision follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2025, which recommended Dazublys for marketing authorization. The successful development and regulatory approval of Dazublys align with Aurobindo Pharma’s strategic vision to expand its biosimilars portfolio, with a stated goal of launching at least 10 biosimilars across oncology and immunology segments by 2030.
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