Aurobindo unit gets UK nod for biosimilar breast cancer drug Dazublys

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has secured UK MHRA approval for its trastuzumab biosimilar Dazublys, used in HER2-positive breast and gastric cancer treatment

Hyderabad-based pharma major Aurobindo Pharma on Tuesday announced that its subsidiary CuraTeQ Biologics had received authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market cancer drug Dazublys in the country.

 

The drug, a biosimilar version of the molecule trastuzumab, is used to treat human epidermal growth factor receptor 2 (HER2)-positive breast and gastric cancers. It regulates the HER2 protein that promotes tumour growth. The development follows Dazublys’ approval by the European Commission (EC) for the European Union (EU) market in July this year.

 

The company said Dazublys is the fourth CuraTeQ biosimilar to receive MHRA approval, after Bevqolva in December 2024, Zeflyti in May 2025, and Dyrupeg in June 2025.

 

The approval comes as the drugmaker seeks to expand its biosimilars portfolio, particularly in Europe. “Dazublys, Zeflyti, and Dyrupeg have already achieved approval in the broad EU market,” the company added. According to its FY24 annual report, the drugmaker already covers around 75 per cent of the European generic market with an extensive portfolio of marketed products.

 

The European market helped the company record a 4 per cent year-on-year rise in overall revenue from operations, reaching Rs 7,868 crore in the June quarter, despite a 10.2 per cent on-year decline in consolidated profit after tax (PAT) for the same period.

 

The decline in profits was attributed to lower sales in its active pharmaceutical ingredients (API) business and the US market. On Tuesday, Aurobindo Pharma’s stock fell 2.07 per cent, closing at Rs 1,045.30 apiece on the Bombay Stock Exchange (BSE).