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Aurobindo Pharma's subsidiary CuraTeQ Biologics secures marketing approval for trastuzumab biosimilar ‘Dazublys'
Aurobindo Pharma's wholly owned step-down subsidiary, CuraTeQ Biologics s.r.o., has achieved a major milestone with the European Commission granting marketing authorization for Dazublys™, its trastuzumab biosimilar.
This approval follows the positive opinion issued by the European Medicines Agency's (EMA) CHMP in April 2025, recommending the product for authorization. Dazublys™ is a biosimilar of trastuzumab, a widely used monoclonal antibody in the treatment of HER2-positive breast and gastric cancers.
With this latest approval, Dazublys™ becomes CuraTeQ's third EMA-approved biosimilar, following Dyrupeg™ (approved in April 2025) and Zefylti™ (approved in February 2025). It also marks the fourth biosimilar approval for CuraTeQ in the European region, including Bevqolva™, which received a green light from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in December 2024.
This continued string of regulatory successes further strengthens Aurobindo Pharma's global biosimilar portfolio and underscores the company's commitment to expanding access to high-quality, affordable biologics in key regulated markets.
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