Data from Pharmawand - Curated by EPG Health - Date added 23 January 2019

Samsung Bioepis Co., Ltd. announced that the FDA has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab), across all eligible indications, namely adjuvant treatment of 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.

.Ontruzanrt is Samsung Bioepis’ first oncology biosimilar to receive FDA approval, and will be marketed and distributed in the United States (US) by Merck Inc.,

Comment: Ontruzant was also approved by the European Commission (EC) in November 2017, and has since been launched in a growing number of European countries.

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