A Samsung Bioepis study published in JAMA Network Open has demonstrated that SB3, its proposed trastuzumab biosimilar is comparable to Genentech’s Herceptin®. In their analysis of RCT outcomes of SB3 and Herceptin®, long term cardiac safety and efficacy were comparable after six years.
In February 2022, Samsung Bioepis announced that Health Canada has approved its Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.