Aurobindo arm's biosimilar for breast cancer gets EMA panel nod
'The CHMP has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), CuraTeQ Biologics s.r.o. trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers,' Aurobindo Pharma said on Saturday.
The 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, pharmacodynamics, efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys will be available for use across EU member states, Aurobindo Pharma Director and CEO Biologics, Vaccines and Peptides Satakarni Makkapati said.
'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,' he said in a release.
Aurobindo Pharma Vice Chairman and MD Nithyananda Reddy said the company is working towards building biosimilars as one of the core businesses. 'By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments,' he said.
On Trastuzumab, which a monoclonal antibody, the company said the biosimilar 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 tumour growth and potentially immune system activation to destroy cancer cells.
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