CHMP recommends Trazimera (trastuzumab biosimilar) to treat HER-2 breast cancer and gastric cancer.- Pfizer.

Pfizer Inc. has announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Trazimera, a potential biosimilar to Herceptin (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The regulatory submission is supported with a comprehensive data package and totality of evidence demonstrating a high degree of similarity to the originator product. This includes results from the primary REFLECTIONS B327-02 clinical comparative study, which demonstrated clinical equivalence and found no clinically meaningful differences between Trazimera and Herceptin in patients with first line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program for the proposed biosimilar trastuzumab, Trazimera has been studied in nearly 500 patients and across more than 20 countries to date.

Comment: Roche/Genentech has sued for infringement of 40 patents protecting its Herceptin. In a complaint in Delaware federal court, Roche claims that Pfizer's FDA application for its proposed biosimilar amounts to patent infringement. Roche is asking the court to agree—and to block a potential launch until at least 2019.