SB3, a trastuzumab (Herceptin) biosimilar developed by Merck and Samsung Bioepsis, induced a rate of breast pathologic complete response (bpCR) similar to trastuzumab in women with HER2-positive breast cancer, according to results from a phase III study of 800 patients.
In December 2017, the FDA approved another trastuzumab biosimilar, MYL-1401O (Ogivri; trastuzumab-dkst), for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.
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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