Aurobindo Pharma Limited, through its wholly owned step-down subsidiary CuraTeQ Biologics s.r.o., has achieved a significant regulatory milestone with the approval of Dazublys™ by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Dazublys™ is a trastuzumab biosimilar, designed to provide a high-quality alternative to reference biologics used in oncology therapy.

Earlier, in July 2025, Dazublys™ had received marketing authorisation from the European Commission (EC), enabling its commercialisation across the European Union. With the UK MHRA approval, CuraTeQ Biologics has expanded its reach into one of the most regulated pharmaceutical markets, further solidifying Aurobindo Pharma’s position in global biosimilars.

Portfolio Context

Dazublys™ represents CuraTeQ’s fourth biosimilar approved by MHRA, following:

• Bevqolva™ – Approved in December 2024

• Zefylti™ – Approved in May 2025

• Dyrupeg™ – Approved in June 2025

All three—Zefylti™, Dyrupeg™, and now Dazublys™—have also received approval from the European Union, reflecting CuraTeQ’s consistent focus on regulatory compliance and quality standards in highly regulated markets.

This approval strengthens Aurobindo Pharma’s oncology biosimilar portfolio, positioning the company to address growing demand for affordable cancer therapies in the UK and EU.

Strategic Implications

By securing marketing authorisation from MHRA, CuraTeQ Biologics achieves several strategic objectives:

• Expands geographical footprint in regulated European markets.

• Increases global market access for trastuzumab biosimilars, supporting revenue growth.

• Enhances pipeline credibility and strengthens Aurobindo Pharma’s reputation as a leading biosimilar manufacturer.

The UK MHRA approval also reinforces the company’s commitment to quality, safety, and regulatory compliance, ensuring patients receive accessible and effective therapies.

About CuraTeQ Biologics

CuraTeQ Biologics s.r.o. is a wholly owned step-down subsidiary of Aurobindo Pharma, focusing on development, manufacturing, and commercialisation of biosimilars for global markets. The company has built a robust portfolio of oncology, immunology, and specialty biologics, demonstrating regulatory excellence and high-quality manufacturing standards.

Through CuraTeQ Biologics, Aurobindo Pharma is expanding its global presence and leveraging its expertise to make affordable biologics available worldwide.

Outlook

With Dazublys™ now approved in both the European Union and the UK, Aurobindo Pharma is well-positioned to capitalize on growth opportunities in international oncology markets. The company’s strategy emphasizes regulatory approvals in key geographies, pipeline expansion, and increasing access to high-value biosimilar therapies.

This latest milestone demonstrates Aurobindo Pharma’s commitment to innovative biologics development, global regulatory compliance, and sustainable business growth, reinforcing its leadership in the global biosimilars industry.

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