Big Molecule Watch
December 17, 2021

Samsung Bioepis Clinical Trial Updates

On December 8, Samsung Bioepis announced that it had presented the longest follow-up study results for a trastuzumab biosimilar in patients with HER2-positive early or locally advanced breast cancer.  The five-year study compared long-term survival rates of patients on SB3 (ONTRUZANT®, Samsung Bioepis’ biosimilar of Herceptin®) and Herceptin® (trastuzumab) from the SB3 Phase 3 study.  The results of the follow-up study indicate that the five-year event-free survival of patients on SB3 and those on Herceptin® were comparable, showing a survival rate of 79.8% and 75%, respectively.  The full results of the study were presented at 2021 San Antonio Breast Cancer Symposium on December 8, 2021.

On December 11, Samsung Bioepis also announced the results of its Phase 1 study of SB12, Samsung Bioepis’ biosimilar of Soliris® (eculizumab).  SB12 met all clinical endpoints in the Phase 1 study, including pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles when compared to Soliris®.  The full results of the study were presented at the 63rd American Society of Hematology (AHS) Annual Meeting and Exposition on December 11, 2021.  According to Dong-hoon Shin, Vice President and Medical Lifecycle Team Leader, Samsung Bioepis “will continue to advance our clinical development efforts to demonstrate biosimilarity and quality of our eculizumab biosimilar through Phase 3 study.”

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