Posted by Michael Wonder on 12 Mar 2019
U.S. FDA approves Pfizer's oncology biosimilar Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin
11 March 2019 - Pfizer today announced the United States FDA has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) over-expressing breast cancer and HER2 over-expressing metastatic gastric or gastro-esophageal junction adenocarcinoma.
The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between Trazimera and the originator product. This includes results from the REFLECTIONS B327-02 clinical comparative study that was recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between Trazimera and the originator product in patients with first line HER2 over-expressing metastatic breast cancer.
