FDA Approves Third Trastuzumab Biosimilar

January 18, 2019 – The FDA has granted an approval to SB3 (trastuzumab-dttb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. The approval is based on data sets from 7 clinical trials, which demonstrated similarity in survival outcomes and safety between SB3 and reference trastuzumab in patients with HER2-positive adjuvant and metastatic … (leggi tutto)