[JPM 2026] Samsung Bioepis pledges annual trial entry for new drug candidates

SAN FRANCISCO – Samsung Epis Holdings, the holding company of biosimilar drug developer Samsung Bioepis Co., has pledged to put more effort into developing new drugs while bolstering its biosimilar sector, aiming to advance at least one new drug candidate into clinical trials each year.

“At Samsung Bioepis, we have been strengthening our research, clinical medicine, process, and development capabilities to a global level through the development of biosimilars,” said Kim Kyung-ah, who heads both Samsung Epis Holdings and Samsung Bioepis, during a press conference on the sidelines of the 44th JPMorgan Healthcare Conference in San Francisco on Wednesday.

“Based on this, we are looking to move on to the next level and push for new drug development. As for the first step, we recently received approval (from the US Food and Drug Administration) to apply for clinical trials of the next-generation Nectin (antibody-drug conjugate).”

The event marked the first public appearance of Kim since she took office as head of Samsung Epis Holdings, the new holding unit established following Samsung Biologics’ spinoff of its biosimilar and new drug development operations in November last year. The holding company owns Samsung Bioepis and Epis NexLab as subsidiaries.

According to Kim, Samsung Bioepis plans to begin a Phase 1 clinical trial of SBE303, the firm’s first novel ADC designed to bind to Nectin-4 -- an adhesion protein specifically expressed in tumor cells, including urothelial cancer, lung cancer and breast cancer -- in Korea and the US this year.

“On top of our accumulated capabilities, we want to organically integrate innovative technologies from the outside through an open innovation strategy,” she said.

“As new drug development has uncertainties from a long-term perspective, we aim to earn trust from the market through relentless scientific assessment and distinguished technologies instead of pursuing short-term performance or simply increasing the number of pipelines.”

Pointing out that Samsung Bioepis has launched 11 biosimilar products since its founding in 2012 and now serves patients in 40 countries, the CEO noted that its global sales surpassed 2 trillion won ($1.36 billion) in 2025.

“As we have risen to the leadership of the biosimilar industry, we are going to secure a portfolio of 20 biosimilar products by 2030 to maintain our lead and grow this business,” she said.

To this end, Samsung Bioepis announced that it has begun developing six additional candidates in its biosimilar pipeline -- dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab and ocrelizumab -- and its pembrolizumab biosimilar is already undergoing Phase 1 and 3 clinical trials.

“What separates us from other biotechnology companies is that we already have cash flows from our biosimilar business and we can use that cash to reinvest in developing new drug technologies and products, so we are not considering an external capital raise at this time,” said the CEO.

The Samsung Bioepis leader underscored the surge of artificial intelligence in the biopharmaceutical sector and how it can be utilized in not only improving work efficiency but also in discovering new drug candidates and developing them.

“We are carrying out a state project with a research team at Seoul National University,” said Kim. “By predicting the structure of a protein, we can predict better antibody candidates more quickly with better efficacy.”

Regarding questions lingering over the Trump administration’s policy aimed at lowering drug prices and amid intensifying competition with Chinese and Indian companies, the CEO dismissed such concerns.

“The Trump administration is challenging the hefty price of original products, and the solution for that is biosimilars,” she said. “We predict the biosimilar market to get even bigger. … We have accumulated experience over the last 14 years, and our strength in raw material costs, production levels and process standards ranks among the global top tier.”