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.

”Pfizer is extremely proud to offer expanded biologic treatment options for patients by bringing more affordable, life changing biosimilar medicines to market, and today’s positive recommendation from the CHMP marks one more step forward. Trazimera has the potential to help many patients with HER2 overexpressing cancers across Europe and, if approved, would help address the evolving needs of healthcare systems, physicians, payers and patients, “said Amrit Ray, MD, MBA, Global President, Research & Development, Pfizer Essential Health.

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.

“Many patients with breast and gastric cancers have an HER2 overexpression, which can correlate with poor outcomes and aggressive disease,” 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 Europe, oncologists will have additional treatment options to choose from, which potentially helps our patients have greater access to these medicines.”

Trazimera is Pfizer’s fourth biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. Pfizer’s biosimilars pipeline is progressing and consists of 11 distinct Pfizer and legacy Hospira biosimilar molecules in various stages of development.