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FDA Okays Pfizer's Trastuzumab Biosimilar, Trazimera

Pfizer Inc. (PFE) announced the United States Food and Drug Administration has approved Trazimera or trastuzumab-qyyp, a biosimilar to Herceptin or trastuzumab, for the treatment of human epidermal growth factor receptor-2 or HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal 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 overexpressing metastatic breast cancer.

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