12 March 2019 - - The United States Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, US-based biopharmaceutical company Pfizer Inc. (NYSE: PFE) said.

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.3

Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development. Trazimera is Pfizer's first oncology monoclonal antibody biosimilar and Pfizer's fifth biosimilar to be approved by the FDA.

Trazimera was also approved for use in the EU in July 2018 for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Trazimera is a monoclonal antibody biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow.

Trazimera locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.

As part of the REFLECTIONS clinical trial program, Trazimera has been studied in nearly 500 patients and across more than 20 countries to date.

These include heart problems--such as congestive heart failure or reduced heart function--with or without symptoms.

The risk for and seriousness of these heart problems were highest in people who received both trastuzumab and a certain type of chemotherapy (anthracycline).

In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with Trazimera.