Pfizer's Trazimera, Fourth Herceptin Biosimilar, Gains FDA Approval Amid Intensifying Competition for Roche's Blockbuster
Mar 12, 2019 15:36
CST Updated
15:36
Pfizer
Pharmaceutical R&D Developer
FDA
U.S. Food and Drug Administration
March 12, 2019 /BioValleyBIOON/ -- US pharmaceutical giantPfizer(Pfizer) recently announced that the U.S. Food and Drug Administration (FDA) ApprovedBiosimilarsTrazimera (trastuzumab-qyyp, trastuzumab), for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressionBreast Cancerand the treatment of HER2-overexpressing positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Trazimera is the 18th biosimilar approved in the U.S. market and the fourth approved trastuzumab biosimilar.Biosimilars, the targeted brand-name drug is Roche’s flagship biologic, Herceptin (generic name: trastuzumab). Herceptin is a blockbuster product for Roche, with global sales of CHF 6.98 billion in 2018.
In the US market, patent protection for Herceptin is set to expire in mid-June 2019, and no biosimilars of Herceptin have been launched yet. In this market, there were previously three HerceptinBiosimilarsApproved, respectively: Merck & Co. and Samsung Bioepis’s Ontruzant (approved in January 2019), Celltrion’s Herzuma (approved in December 2018), and Mylan and Biocon’s Ogivri (approved in December 2017).
The approval of Trazimera is based on a comprehensive data package and totality of evidence demonstrating high similarity to the reference product, Herceptin. This includes comparative results from the REFLECTIONS B327-02 clinical study, which confirmed the clinical equivalence of the two products as first-line treatment for HER2-positive metastatic breast cancer, with no clinically meaningful differences. As part of the REFLECTIONS clinical program, Trazimera has been studied in nearly 500 patients across more than 20 countries worldwide.
Notably, Trazimera is the first product approved by Pfizer in the U.S. marketTumorThis is also the fifth biosimilar approved by the company in the U.S. market. In Europe, Trazimera was approved in July 2018 for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Currently, Pfizer’s biosimilar pipeline comprises nine products.Biosimilarsat different stages of development. (Bioon.com)