Sandoz submits BLA for proposed biosimilar trastuzumab to FDA.

Trastuzumab is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers. Sandoz is seeking approval for the same indications as the reference medicine, based on a comprehensive package that includes analytical, preclinical and clinical data.

“Approximately 15-20% of all breast cancer patients have tumors that are HER2-positive and, as these tumors tend to grow more quickly than HER2-negative tumors, getting treated swiftly can be live-saving,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz. “Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US."

Breast cancer is the most commonly diagnosed cancer among women in the US and associated death rates are the second highest of all cancers. It is estimated that about 30% of newly diagnosed cancers in women will be breast cancers in 2021.

As part of the license agreement signed in April 2019, EirGenix, Inc. is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.