We will actively expand our biosimilar portfolio to a total of 20 products by 2030. Starting this year with phase 1 for a new drug candidate of an Antibody-Drug Conjugate (ADC) for bladder cancer for solid tumors including bladder cancer, we will add at least one new drug candidate in pivotal clinical stages every year.
Kim Kyung-ah, president of Samsung Epis Holdings, on Jan. 14 (local time) outlined key business strategies for Samsung Epis Holdings and its subsidiaries Samsung Bioepis and EPIS NexLab at a press briefing on the sidelines of the JP Morgan Healthcare Conference in San Francisco.
Kim said the company will grow into a "Korean big pharma" model by expanding beyond biosimilars into new drug development. Kim said the goal is to build a sustainable new drug development system based on scientific validation and differentiated technology rather than short-term results.
Samsung Epis Holdings is a holding company that was spun off from Samsung Biologics last November and listed on the KOSPI. Kim oversees management of Samsung Epis Holdings and its subsidiaries.
The company develops new drugs through EPIS NexLab, funded by proceeds from Samsung Bioepis' biosimilar business. Since its establishment in 2012, Samsung Bioepis has received approvals for and launched 11 biosimilar products and supplies them to about 40 countries. According to Kim, in 2025 it surpassed 2 trillion won in global sales.
Kim said the company plans to build a biosimilar portfolio of more than 30 products by 2030, adding it is pursuing development of more than 10 additional biosimilars, including global blockbuster drugs such as Keytruda and Dupixent.
On funding for new drug development, Kim said, "We are in the early stages, and we believe cash flow generated from the biosimilar business is sufficient to cover it," adding, "For now, we are not considering external financing." Kim said, "As development progresses, we can keep various options open and review them."
The first pipeline for new drug development is a Nectin-4 Antibody-Drug Conjugate (ADC). It is a bladder cancer targeted therapy candidate that targets a protein called Nectin-4. Kim said, "We recently received IND approval from the Food and Drug Administration (FDA) and plan to enter phase 1 trials in the United States and Korea within the year."
Kim said the company is internally reviewing various modalities, including gene therapy and peptide- and hormone-based therapeutics, and noted it is developing delivery-based technologies to improve the safety of peptide therapeutics in particular. Kim also said the company is keeping all options open, including direct commercialization, joint development, and technology transfer, and will make the best choice after clinical data accumulate.
Kim drew a line under the possibility of developing a biosimilar of a glucagon-like peptide (GLP)-1 class obesity drug. Kim also said EPIS NexLab plans to develop platform technologies that improve the dosing interval of glucagon-like peptide-1 (GLP-1) therapies.
Kim said the company has no plans to develop GLP-1 itself as a biosimilar or generic, explaining that different regulatory regimes by country make approaches to GLP-1 biosimilar development challenging. Kim said GLP-1 is being used to validate platform technologies for extending dosing intervals and ensuring stability.
Kim offered a positive assessment of U.S. drug price reduction policies. Kim said the United States' trend toward lowering drug prices is a factor expanding the biosimilar market and predicted more products will enter the market as approval guidelines are eased. Addressing concerns that competition among biosimilar companies could intensify, Kim emphasized that the core is process complexity and maintaining quality and that the capability to reliably supply global demand is a competitive edge that is not easily matched.
Samsung Epis Holdings is pursuing an open innovation strategy that combines external innovative technologies with its internal research capabilities during new drug development.
Kim Kyung-ah said the company will create synergies by linking group-level healthcare assets—such as venture investment, basic science research, and the Samsung medical network (Samsung Medical Center, Kangbuk Samsung Hospital, etc.)—to new drug development, and explained it can leverage the in-Samsung healthcare ecosystem throughout the new drug development process to improve research and development efficiency.
Kim said Korean corporations have achieved results up to technology transfer, but there are few cases with experience spanning phases 1 to 3, approvals, and commercialization, and added that Samsung Epis Holdings hopes to help create a reference for a Korean big pharma through new drug development.