CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has achieved a significant regulatory milestone as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for Dazublys®. This formulation, a Trastuzumab biosimilar, is designed to treat HER2-positive metastatic and early breast cancers, a segment representing a critical area in global oncology care.

Dazublys®, formulated as a 150 mg powder concentrate for infusion, mimics the action of Herceptin®, the original biologic. Trastuzumab works by targeting the HER2 protein, which is overexpressed in several solid tumors, particularly breast and gastric cancers. By binding to HER2’s extracellular domain, it inhibits cell proliferation, causes tumour cell arrest, and potentially stimulates immune system responses to eliminate malignant cells.

Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides, highlighted that the CHMP’s recommendation was based on robust clinical and analytical data showing no meaningful differences in pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity between Dazublys® and Herceptin®. The final European Commission approval is expected by July 2025, post which Dazublys® will be launched across EU member states.

This endorsement is significant for Aurobindo, being its third biosimilar recommended by CHMP and the fourth approved in Europe. In November 2024, the company received approval for Bevqolva®, a bevacizumab biosimilar, from the UK’s MHRA. These approvals demonstrate Aurobindo’s accelerated biosimilar strategy, reflecting its continued investment in biologic drugs for oncology and immunology.

Mr. Nithyananda Reddy, Vice Chairman and Managing Director of Aurobindo Pharma, remarked on the company’s momentum in the biologics space. He emphasized that this string of approvals within just five months highlights Aurobindo’s capabilities and commitment. By 2030, the company aims to launch 10 or more biosimilars, consolidating its position as a key player in the global biosimilars market.

CuraTeQ Biologics Private Limited, headquartered in Hyderabad, is the R&D and manufacturing arm dedicated to biologics. It focuses on cost-effective and high-quality biosimilars for oncology and autoimmune diseases. With 14 biosimilars in its pipeline, the company has end-to-end capabilities, from producing bulk drug substances to fill-finish operations.

Aurobindo Pharma, as a parent company, brings its global pharmaceutical infrastructure to support CuraTeQ’s biosimilar ambitions. Operating in over 150 countries, Aurobindo’s vast manufacturing network, which includes 30+ facilities approved by authorities such as the USFDA, UK MHRA, Japan PMDA, and WHO, bolsters the commercial readiness of Dazublys®.

The Trastuzumab market in Europe is competitive but presents ample opportunity due to increasing incidences of HER2-positive cancers. Dazublys® joins a field of existing biosimilars but differentiates itself by demonstrating analytical and clinical comparability that supports its safety and efficacy profile.

The development and regulatory journey of Dazublys® underscores Aurobindo’s transition from being a generic player to an innovation-driven pharmaceutical firm. The biosimilar segment, especially in oncology, remains high-growth, and companies like Aurobindo are leveraging this trend to meet unmet clinical needs while ensuring affordability.

The company also recognizes the role of biosimilars in healthcare sustainability, helping health systems manage costs without compromising care quality. Biosimilars such as Dazublys® can reduce treatment costs by up to 30-50%, increasing patient access in markets that are otherwise burdened by expensive originator drugs.

The journey of Dazublys® from development to regulatory approval also reflects the maturity of CuraTeQ’s research and clinical operations, showcasing compliance with the strict regulatory standards of the EMA. The positive opinion is a result of rigorous analytical assessments, comparative non-clinical studies, and randomized clinical trials, which showed equivalence to Herceptin® in all critical parameters.

With this, Aurobindo strengthens its strategic focus on biologics, which, alongside its traditional generics business, creates a diversified revenue stream. It signals to investors and stakeholders that the company is evolving to stay relevant in a market that increasingly values complex therapies and innovation.

In the backdrop of global shifts towards precision medicine and biosimilar adoption, Dazublys® represents not just another product, but a symbol of Aurobindo's transformation. The company’s biosimilar roadmap is aligned with both market demand and policy directions in regulated markets, particularly the EU, where biosimilar penetration is strongly supported by reimbursement frameworks.

To summarize, the positive CHMP opinion for Dazublys® is a significant regulatory and strategic victory for Aurobindo Pharma and CuraTeQ Biologics. It reaffirms the company's technical capabilities, market insight, and global aspirations. As the European Commission decision approaches, stakeholders eagerly await Dazublys®’s commercial debut, which could potentially enhance access to life-saving cancer therapies across Europe

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