Pfizer said Monday it got approval for Trazimera (trastuzumab-qyyp) in USA, which is a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
According to the press release, the FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between Trazimera and the originator product.
“This is an important milestone in the U.S. which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, Global President, Pfizer Oncology.
Trazimera is Pfizer’s first oncology monoclonal antibody (mAb) biosimilar and Pfizer’s fifth biosimilar to be approved by the FDA. It was also approved for use in the EU in July 2018.