New Biosimilar Therapy Available for Early and Metastatic HER2-overexpressing Breast Cancer, Metastatic Gastric Cancer

Patients should be selected for therapy based on the FDA approved companion diagnostic for a trastuzumab product.

Trastuzumab-dttb (Ontruzant, Samsung Bioepis Co, Ltd), a biosimilar of the reference biologic medicine trastuzumab (Herceptin) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the United States.

Patients should be selected for therapy based on the FDA approved companion diagnostic for a trastuzumab product.

Trastuzumab-dttb is available in both 150mg single-dose vials and 420mg multi-dose vials. The drug’s launch in the US follows the approval from the FDA in January 2019 for the 150 mg vial, and the March 2020 approval for the 420mg vial.

Christopher Ko, President and Chief Executive Officer, Samsung Bioepis, said in a press release that the launch of trastuzumab-dttb is a milestone for patients in need of the treatment. “While we understand that this is an unprecedented time for our hospitals and health care workers, we at Samsung Bioepis remain steadfastly committed to the patients we serve through our efforts to ensure the continued supply of our medicines through collaboration with our manufacturing and commercial partners,” he added.

REFERENCE

Samsung Bioepis announces US launch of ONTRUZANT (trastuzumab-dttb) for Early and Metastatic HER2-overexpressing Breast Cancer and Metastatic Gastric Cancer [news release]. Incheon, Korea; BusinessWire: April 15, 2020. https://www.businesswire.com/news/home/20200415005252/en/Samsung-Bioepis-Announces-Launch-ONTRUZANT%C2%AE-trastuzumab-dttb-Early. Accessed April 15, 2020.