Medication Monitor

Generic Name (Trade Name—Company)
March 13, 2019


FDA approves biosimilar to trastuzumab

Pfizer announced FDA approval of trastuzumab-qyyp, a biosimilar to trastuzumab (Herceptin), for treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between trastuzumab-qyyp and trastuzumab. This includes results from the REFLECTIONS B327-02 clinical comparative study recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between trastuzumab and the originator product in patients with first-line, HER2-overexpressing metastatic breast cancer.

Trastuzumab is a monoclonal antibody biosimilar that targets HER2, a protein found on the surface of some cancer cells that can stimulate the cells to divide and grow. The agent locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.