Samsung Epis targets nine additional biosimilars, drug development expansion in growth strategy

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline growth, targeting nine additional biosimilars by 2030.

Kim Kyung-ah, president and CEO of Samsung Epis Holdings and Samsung Bioepis, answers questions from the Korean reporters at a press event held on the sidelines of the 44th J.P. Morgan Health Care Conference in San Francisco on Jan. 14. [SAMSUNG EPIS HOLDINGS]

SAN FRANCISCO — Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline growth, targeting nine additional biosimilars by 2030 and at least one new drug candidate entering the main clinical stage each year.

“That would bring our biosimilar portfolio to a total of 20 products by 2030,” said Kim Kyung-ah, president and chief executive officer of Samsung Epis Holdings and Samsung Bioepis, speaking to Korean media at a press conference held on the sidelines of the 44th J.P. Morgan Health Care Conference in San Francisco on Wednesday. “We have also received investigational new drug clearance for the first novel drug developed by Samsung Bioepis, which will enter our clinical program this year.”

Samsung Epis Holdings was formed in November 2025 as a holding company that wholly owns Samsung Bioepis, which spun off from Samsung Biologics. The restructuring was designed to separate Samsung Biologics’ core contract manufacturing business from biosimilar and new drug development.

The holding company oversees two subsidiaries: Samsung Bioepis, which focuses on biosimilars and new drug development, and Epis NexLab, a newly established unit tasked with advancing platform-based biotechnological innovations.

A view of Samsung Bioepis in Incheon [SAMSUNG EPIS HOLDINGS]

“As many of you are aware, peptide hormone therapies, such as GLP-1–based treatments, face challenges in achieving long dosing intervals due to their inherent instability,” Kim said. “To address this, we plan to establish core technologies through Epis NexLab that enable more stable, long-acting administration of inherently unstable modalities such as peptides, including advanced delivery systems.”

Samsung Bioepis’ first novel drug candidate is an antibody–drug conjugate (ADC) known as SBE303, which is entering clinical development to treat multiple types of solid tumors, including urothelial, lung and breast cancers. Kim added that the company’s next clinical-stage candidate, expected to follow next year, will also be an ADC.

In its biosimilar business, Samsung Bioepis currently has 11 products commercialized across 40 countries. The company is developing biosimilars for seven blockbuster drugs — defined as products with annual sales exceeding $1 billion — including Keytruda, Dupixent, Tremfya, Taltz, Enhertu, Entyvio and Ocrevus.

Kim dismissed concerns that intensifying competition in the biosimilar market, combined with the Trump administration’s drug price-reduction policies, could undermine growth prospects for biosimilar makers.

“The administration’s approach to drug pricing extends beyond direct price cuts and includes regulatory reforms, such as easing biosimilar approval guidelines, aimed at reducing overall health care costs,” she said.

“As these barriers come down, more biosimilar products are expected to enter the market, and price competition will intensify,” Kim added. “However, biosimilars require sophisticated manufacturing processes and consistent high quality. Maintaining a stable and reliable supply is also critical, and smaller players often struggle to meet these demands at scale. Companies with proven capabilities in quality control, sustainable supply and cost efficiency are therefore well positioned to remain competitive.”

BY LEE JAE-LIM [lee.jaelim@joongang.co.kr]