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FDA Approves New Dose of Trastuzumab Biosimilar Ontruzant

Jason M. Broderick @jasoncology
Published: Tuesday, Mar 24, 2020

The FDA has approved a 420-mg multidose vial of trastuzumab-dttb (SB3; Ontruzant), according to Samsung Bioepis Co., Ltd., the manufacturer of the trastuzumab (Herceptin) biosimilar.1 

The European Commission approved SB3 in November 2017.


  1. Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates Published Online. March 24, 2020. Accessed March 24, 2020.
  2. Ontruzant prescribing information. FDA." . Accessed January 18, 2019.
  3. 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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