Aristopharma Ltd. has launched Biosimilar Trastuzumab, preparation of Trastuzumab INN 440 mg lyophilized powder for IV infusion.

Trastuzumab is an anti-HER2 monoclonal antibody used to treat HER2-positive breast and gastric cancers. It is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of human epidermal growth factor receptor 2 (HER2). By binding to HER2, Trastuzumab inhibits HER2-mediated signaling pathways involved in cell growth and proliferation and promotes antibody-dependent cellular cytotoxicity (ADCC), thereby inhibiting the growth and survival of HER2-overexpressing tumor cells. In patients with HER2-positive metastatic breast cancer, Trastuzumab-containing treatment significantly improves objective response rate (ORR) and progression-free survival (PFS). In the adjuvant treatment of HER2-positive early breast cancer, Trastuzumab significantly improves disease-free survival (DFS) and reduces the risk of distant recurrence. In HER2-positive metastatic gastric cancer, Trastuzumab, in combination with chemotherapy, has demonstrated an overall survival benefit in appropriately selected patients.