At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herceptin® (trastuzumab). The biosimilar is indicated for HER2-positive metastatic and early breast cancers. According to Aurobindo, European Commission approval is expected in July 2025.
The first trastuzumab biosimilar was approved in the EU in November 2017 and in the US in December 2017.