Overview
- At the J.P. Morgan Healthcare Conference in San Francisco, CEO Kyung-Ah Kim detailed a 2030 objective to assemble a 20-product biosimilar portfolio.
- The company named six new biosimilar candidates: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.
- The FDA cleared an IND in December 2025 for SBE303, a Nectin-4–targeting antibody-drug conjugate, with a first-in-human Phase 1 study planned in 2026 in the United States and Korea.
- Samsung Bioepis now markets 11 biosimilars in more than 40 countries, and its pembrolizumab biosimilar is in Phase 1 and 3 clinical trials.
- The company emphasized continued investment in ADCs, an annual cadence of moving a novel therapeutic into clinical study, and Epis NexLab’s peptide-based delivery platform work.