Aurobindo Pharma arm gets marketing nod for Dazublys from European Commission
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Hyderabad: Aurobindo Pharma has announced that CuraTeQ Biologics, a wholly owned step-down subsidiary of the company, has obtained marketing authorization from the European Commission for Dazublys, its trastuzumab biosimilar version.
Earlier in April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dazublys, recommending its marketing authorization.
This is CuraTeQ’s third biosimilar to be approved by EMA after the approval of Dyrupeg in April 2025 and Zefylti in February 2025, and the fourth overall in the EU, alongside the approval of Bevqolva by the UK’s MHRA in December 2024.
Read also: Aurobindo Pharma arm gets marketing authorization in UK for Dyrupeg
CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. The company is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ's pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments. It has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products.
Its parent company, Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 30 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s product portfolio is spread over seven major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and AntiAllergic, supported by a strong R&D set-up.
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