CuraTeQ Biologics receives positive opinion for biosimilar Dazublys® from EMA

CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys® (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells.

Commenting on the update, Dr. Satakarni Makkapati, Director of Aurobindo Pharma and CEO Biologics, Vaccines and Peptides stated, "The CHMP's positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys® and the reference biologic product Herceptin® in terms of pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys® will be available for use across EU member states. This marks our third biosimilar to receive CHMP's endorsement and the fourth overall in the EU, alongside the approval of Bevqolva® (a bevacizumab biosimilar) by the MHRA in November 2024. Biosimilars are playing an important role in improving cancer care, and we remain committed to expanding our biosimilars portfolio to address the unmet needs of patients."

Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, "The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies."

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1217.85 as compared to the previous close of Rs. 1257.60. The total number of shares traded during the day was 23932 in over 1656 trades.

The stock hit an intraday high of Rs. 1267.45 and intraday low of 1211.00. The net turnover during the day was Rs. 29405809.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 CuraTeQBiologics PositiveOpinion Biosimilar Dazublys EMA