European Commission Approves Trastuzumab Biosimilar

The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval follows the recommendation from the Committee for Medicinal Products for Human Use in May 2018.

The EC approval is based on a comprehensive submission package which demonstrated a high degree of similarity for Trazimera and the originator product. The data included results from the REFLECTIONS B327-02 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Trazimera and the originator product in patients with first-line HER2-overexpressing metastatic breast cancer.

More About Trazimera

Trazimera is a monoclonal antibody biosimilar of the originator biologic medicine, trastuzumab, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. It locks on to the HER2 protein and blocks the receptor, stopping cell division and growth.

Trazimera has been studied in nearly 500 patients and across more than 20 countries to date as part of the REFLECTIONS studies.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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