Is Trastuzumab available in the United States?

Trastuzumab (Trastuzumab) has been approved for marketing by the U.S. Food and Drug Administration (FDA). In December 2017, the FDA approved OGIVRI (trastuzumab-dkst) as a biosimilar of trastuzumab for the treatment of patients with breast cancer or metastatic gastric cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Based on clinical data, it exhibits similar biological properties to trastuzumab. While OGIVRI is the first biosimilar approved in the United States to treat breast or gastric cancer, it is the second biosimilar approved in the United States to treat cancer.

Herzuma is a biosimilar approved in December 2018 for the treatment of breast cancer that overexpresses HER2. Trastuzumab-anns is another biosimilar approved by the FDA in June 2019, and ONTRUZANT is another biosimilar of Herceptin that was approved by Health Canada in February 2022. The target of trastuzumab is human epidermal growth factor receptor 2 (HER2), also known as ERBB2.

Trastuzumab’s original drug is on the market in China and has entered the scope of Class B medical insurance, but it may be limited to patients who meet the indications of this drug, such as patients with HER2-positive metastatic breast cancer and its adjuvant and neoadjuvant treatment or HER2-positive metastatic gastric cancer. The price is about 6,000 yuan, and the cost for one year of use may depend on the usage and dosage. The original trastuzumab drug has also been launched overseas. The drug ingredients of domestic and foreign original drugs are basically the same. For specific prices and drug details, you can consult the medical consultant. There is currently no generic drug of trastuzumab on the market.