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Aurobindo Pharma Limited, through its wholly-owned step-down subsidiary CuraTeQ Biologics, has achieved a significant regulatory milestone with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting marketing authorization for Dazulbys, its trastuzumab biosimilar. This approval marks a critical step forward in expanding affordable cancer treatment options and reinforces Aurobindo’s commitment to advancing biosimilar therapies globally.
Key Highlights of the MHRA Approval for Dazulbys
Dazulbys is a biosimilar to Roche’s Herceptin (trastuzumab), indicated for treatment of HER2-positive breast and gastric cancers.
The MHRA approval follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) earlier in 2025.
This approval is CuraTeQ’s third biosimilar endorsement by the MHRA, following the earlier approvals of Bevqolva (bevacizumab biosimilar) and Zefylti (filgrastim biosimilar).
The biosimilar demonstrated comparable quality, safety, efficacy, pharmacokinetics, and immunogenicity relative to the reference product during extensive clinical evaluations.
Dazulbys offers a cost-effective alternative to Herceptin, addressing unmet patient needs in oncology by improving access to high-quality treatments.
The European Commission’s marketing authorization is anticipated shortly, enabling launch across EU member states.
CuraTeQ’s portfolio currently includes fourteen biosimilars focused on immunology and oncology segments, positioning the company as a key player in global biosimilar markets.
Aurobindo Pharma’s Strategic Focus and Vision
Aurobindo Pharma aims to be a leading provider of biosimilars by 2030, targeting launch of at least ten new biosimilar products, particularly in oncology and immunology.
The company leverages its robust R&D capabilities and integrated manufacturing facilities based in Hyderabad, India.
Aurobindo’s Vice Chairman and Managing Director highlighted that rapid successive approvals validate its long-term investments and technological expertise.
Biosimilars are central to Aurobindo’s strategy to offer affordable, clinically effective alternatives to biologic drugs, thereby enhancing patient care on a global scale.
Oncology Biosimilars: Addressing Global Healthcare Challenges
Trastuzumab biosimilars like Dazulbys are instrumental in reducing treatment costs for pervasive cancers that overexpress the HER2 protein.
HER2-positive breast and gastric cancers traditionally require costly biologic therapies, limiting access in many regions.
Biosimilars provide equivalent therapeutic benefits, enabling healthcare systems to optimize budgets and serve broader patient populations.
Regulatory approvals by stringent agencies like MHRA and EMA underscore the rigorous standards biosimilars must meet, assuring clinicians and patients of their safety and effectiveness.
About CuraTeQ Biologics
CuraTeQ Biologics Private Limited is a Hyderabad-based global biopharmaceutical company wholly owned by Aurobindo Pharma Limited. With state-of-the-art capabilities spanning drug substance manufacturing to fill-finish and packaging, CuraTeQ develops biosimilars targeting cancer and autoimmune diseases.
The company’s pipeline focuses on complex biologics requiring advanced production technologies.
CuraTeQ’s success in securing multiple major regulatory approvals reflects its scientific competence and commitment to enhancing treatment accessibility.
What Lies Ahead
With Dazulbys’ approval, Aurobindo Pharma stands poised to strengthen its presence in European and international biosimilar markets. The launch will support efforts to lower oncology treatment costs and extend outreach to underserved populations.
Ongoing clinical developments for additional biosimilars continue at CuraTeQ’s Hyderabad facilities.
Market launch and collaborations with healthcare providers will be critical in maximizing patient access.
The company continues to monitor regulatory landscapes to fast-track availability in new jurisdictions.
Conclusion: A New Chapter in Affordable Cancer Care
The MHRA approval of Dazulbys by CuraTeQ Biologics is a landmark achievement that not only enriches Aurobindo Pharma’s biosimilar portfolio but also exemplifies the transformative potential of biosimilars in modern medicine. By delivering cost-effective, innovative oncology therapies, Aurobindo contributes significantly to enhancing global health outcomes.
Sources: CuraTeQ Biologics, Aurobindo Pharma official releases, CNBC TV18, European Medicines Agency, MHRA
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