Samsung Bioepis Announces Four-Year Follow-Up Data for its Trastuzumab Biosimilar and 24-Week Interim Results from Phase 3 Trial of its Proposed Ranibizumab Biosimilar

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Samsung Bioepis Co., Ltd. announced on Friday that the four-year follow-up data from a Phase 3 study for ONTRUZANT, a biosimilar of HERCEPTIN (trastuzumab), will be presented later this month at the ASCO20 Virtual Scientific Program.  The data are from an ongoing five-year follow-up study assessing the cardiac safety and survival outcomes of a group of members from the Phase 3 study patients.  875 patients participated in the Phase 3 study and completed neoadjuvant and adjuvant therapy for one year, and 367 of these patients were enrolled in the five-year follow up.

According to Samsung Bioepis, cardiac safety was comparable between ONTRUZANT and HERCEPTIN, with no occurrence of symptomatic congestive heart failure and a very low incidence of asymptomatic significant left ventricular ejection fraction decrease, and four-year event-free survival rates and overall survival rates were comparable as well. 

Samsung Bioepis also announced on Monday 24-week interim results for SB11, a biosimilar candidate of LUCENTIS (ranibizumab), in a phase 3 clinical trial of patients with neovascular age-related macular degeneration (nAMD).  According to Samsung Bioepis, SB11 met all primary endpoints in the study, including equivalent efficacy in terms of change in best corrected visual activity at Week 8 and central subfield thickness at Week 4 to reference ranibizumab.  As we have previously reported, Samsung Bioepis announced in November 2019 that it had entered into a new commercialization agreement with Biogen covering the United States, Canada, Europe, Japan, and Australia for SB11 and SB15, a pre-clinical biosimilar candidate referencing EYLEA (aflibercept).

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