• Trazimera is Pfizer's first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA.
• Herceptin brought in $2.5 billion in the US alone in 2016

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved Trazimera biosimilar to Herceptin (trastuzumab), 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.

“ Trazimera has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease,”3,4 said Professor Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Hematology and Medical Oncology. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”

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 originator product in patients with first line HER2 overexpressing metastatic breast cancer.

Trazimera is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, 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 is Pfizer’s fourth biosimilar and first therapeutic oncology biosimilar to receive a positive CHMP opinion from the EMA. The company has a large and active portfolio of biosimilar products. A 2017 Forbes article mentioned that Pfizer is targeting a $7.5 billion addressable market with its biosimilar program. https://www.forbes.com/sites/greatspeculations/2017/11/28/how-large-is-p...

Herceptin brought in $2.5 billion in the US alone in 2016 and Roche has acted aggressively to protect the blockbuster.