European Commission approves Pfizer’s first oncology biosimilar

Jul 31 2018

Pfizer Inc. today announced the European Commission (EC) has approved TRAZIMERA^™, a 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," 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."

Richard Blackburn, Global President, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars said "The approval of TRAZIMERA, Pfizer's first oncology biosimilar, is another significant step in our quest to introduce more treatment options for patients in Europe. Pfizer is investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines."