FDA approves third Herceptin biosimilar with Samsung Bioepis\' Ontruzant

FDA approves third Herceptin biosimilar with Samsung Bioepis' Ontruzant

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), in the same indications as its reference product.

This includes three cancer indications: as an 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.

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Original Article: FDA approves third Herceptin biosimilar with Samsung Bioepis' Ontruzant

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