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FDA Approves Third Trastuzumab Biosimilar

Gina Columbus @ginacolumbusonc
Published: Friday, Jan 18, 2019

The FDA has granted an approval to SB3 (Ontruzant; trastuzumab-dttb), a trastuzumab (Herceptin) biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

The European Commission approved SB3 in November 2017.


  1. Ontruzant prescribing information. FDA." . Accessed January 18, 2019.
  2. Pivot X, Bondarenko I, Nowecki Z, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2–positive early breast cancer [published online January 26, 2018]. J Clin Oncol. doi: 10.1200/JCO.2017.74.0126.

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