FDA approves Ontruzant biosimilar for all indications of Herceptin.- Samsung Bioepis + Merck Inc.
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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