FDA Approves Pfizer’s Oncology Biosimilar Trazimera™

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

“This is an important milestone in the U.S. which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

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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 “Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients,” said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center. “With the availability of biosimilars like TRAZIMERA in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”

Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development. TRAZIMERA is Pfizer’s first oncology monoclonal antibody (mAb) 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 (mAb) 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.

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