Home Alzheimer’s Disease FDA Approves Multi-Dose Vial of Trastuzumab Biosimilar

FDA Approves Multi-Dose Vial of Trastuzumab Biosimilar

The FDA has approved a 420 mg multi-dose vial of trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab (Herceptin), according to Samsung Bioepis, the agent’s developer.1

Trastuzumab-dttb was already approved as a 150 mg single-dose vial by the FDA in January 2019 across all eligible indications, including 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.

The European Commission approved the biosimilar in November 2017.

The biosimilar is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer, including:

  • As part of a treatment regimen containing doxorubicin (Lipodox), cyclophosphamide, and either…

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