Trazimera, Biosimilar to Herceptin, Gains Approval

The FDA approved trastuzumab-qyyp (Trazimera, Pfizer), a biosimilar to Herceptin (Genentech) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The approval was based on a review of a comprehensive data package, which demonstrated a high degree of similarity between trastuzumab-qyyp and the originator product. This includes results from the REFLECTIONS B327-02 clinical comparative trial, which showed