Friday, August 29, 2025

Aurobindo Pharma arm secures UK regulator’s approval for breast cancer treatment drug

Date:

Aurobindo Pharma Ltd on Tuesday (August 26) announced that its subsidiary has received authorisation from the regulatory agency in the United Kingdom to market its cancer treatment drug.The wholly-owned step-down subsidiary of Aurobindo Pharma, CuraTeQ Biologics s.r.o., has secured a marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to market Dazublys, a trastuzumab biosimilar version, the company informed the stock exchanges in a filing.

The current development follows the approval given to Dazublys by the European Commission (EC) for the European Union market in July 2025.

Dazublys is used to treat HER2-positive breast and gastric cancers. The drug regulates the HER2 protein that promotes tumour growth.The said approval marks CuraTeQ’s fourth biosimilar to gain MHRA approval, after Bevqolva in December 2024, Zefylt in May 2025, and Dyrupeg in June 2025. Also noteworthy is that Dazublys, Zefylti, and Dyrupeg have also achieved approval in the broad European Union market, the company said.

In an exclusive interview with CNBC TV-18 on August 21, Aurobindo Pharma’s Chief Financial Officer (CFO), Santhanam Subramanian, confirmed that the company has entered into a Non-Disclosure and Confidentiality agreement for its potential acquisition of Zentiva, and talks are currently at a “very early stage”.According to Subramanian, the inclusion of Zentiva into Aurobindo Pharma’s strategic vision aligns well due to Zentiva’s European base; however, any definitive statements on the potential outcome remain premature owing to the early stage of negotiations. If an agreement materialises, Subramanian anticipates an announcement could be made within the next two months.

Aurobindo Pharma currently holds assets worth $140 million and sources 75% of its revenue from the US and European markets, consolidating its strong financial position.

Subramanian iterated that while considering sizable entities for acquisitions is not fundamentally flawed, the company will exercise caution to avoid overpayment in any prospective deal. He further indicated that Aurobindo Pharma would prefer to commit to deals with single-digit multiples.

Shares of Aurobindo Pharma were trading 1.59% lower at ₹1050.4 apiece on the BSE at 10:36 AM on Tuesday.

Catch live market updates with CNBC-TV18.com’s blog

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