The FDA approved trastuzumab-dttb (Ontruzant, Samsung Bioepis) for all eligible indications of the reference product, Herceptin (Genentech).
Trastuzumab-dttb can be used as an adjuvant therapy for HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.