Aurobindo Pharma Limited has informed the Exchange regarding a press release dated April 26, 2025, titled "CuraTeQ Biologics s.r.o, a wholly owned step-down subsidiary of the Company, receives Positive Opinion from CHMP for Dazublys?, a Trastuzumab Biosimilar".
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Aurobindo Pharma's wholly owned step-down subsidiary CuraTeQ Biologics s.r.o has received a Positive Opinion from the European Medicines Agency's CHMP for Dazublys, its proposed Trastuzumab biosimilar. Trastuzumab is a biosimilar version of the widely used breast cancer therapy Herceptin. A Positive Opinion from CHMP is a key regulatory milestone that typically paves the way for formal marketing authorisation in the European Union. The development strengthens Aurobindo's biosimilars pipeline and expands its presence in the high-value oncology biosimilars segment in Europe.
This is a positive regulatory signal for Aurobindo Pharma as it brings a new biosimilar product closer to EU commercialisation, potentially adding to future revenue from its European business. Investors may view this as progress in the company's high-margin biosimilars strategy.