Posted by Michael Wonder on 24 Mar 2020
Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb)
24 March 2020 - 150 mg and 420 mg vial of Ontruzant are now approved.
Samsung Bioepis today announced that the U.S. FDA has approved a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab).
Ontruzant was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastro-esophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.
