Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Trazimera (trastuzumab-qyyp), an oncology biosimilar to Genentech’s Herceptin (trastuzumab).
Trazimera has been approved to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Pfizer Oncology global president Andy Schmeltz said: “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.
“We are proud to be able to offer treatment options that can help address the diverse needs of patients.”
Trazimera was approved based on evaluation of a comprehensive data package, which showed a high degree of similarity with the originator product.
The data from the Reflections B327-02 clinical comparative study has demonstrated clinical equivalence, 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, said Pfizer.
Trazimera is the Pfizer’s first oncology mAb biosimilar, as well as the fifth biosimilar approved by the FDA.
In July 2018, Trazimera secured approval in the EU to treat HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Trazimera is a monoclonal antibody (mAb) biosimilar of Herceptin that targets HER2, which is a protein observed on the surface of some cancer cells that can trigger the cells to divide and grow.
Trazimera adheres to the HER2 protein and restricts the receptors to stop cell division and growth.
Under Reflections clinical trial program, Trazimera has been assessed in around 500 patients and across more than 20 countries.
Stanford Comprehensive Cancer Institute clinical research associate director Dr Mark Pegram said: “With the availability of biosimilars like Trazimera in the US, oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need.”
Pfizer’s oncology division produces 18 approved cancer medicines and biosimilars to treat more than 20 conditions, including breast, prostate, kidney, lung and hematology.