European Commission Approves Biosimilar of Trastuzumab for HER2-Positive Breast Cancer
Posted: Monday, August 6, 2018
The European Commission has approved Trazimera, a monoclonal antibody biosimilar to trastuzumab (Herceptin), for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.
The European Commission approval is based on a comprehensive submission package, which demonstrated a high degree of similarity for Trazimera and the originator product. The data included results from the REFLECTIONS B327-02 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between the biosimilar and the originator product in patients with first-line HER2-overexpressing metastatic breast cancer. The REFLECTIONS studies include nearly 500 patients from more than 20 countries.
