Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone.

In 2000, Samsung began its biopharmaceutical research and has successfully founded Samsung Biologics and Samsung Bioepis in 2011 and 2012, respectively. Samsung Bioepis initially began as a joint venture between Samsung Biologics and Biogen, and in 2022, Samsung Biologics purchased Biogen’s stake in order to wholly own Samsung Bioepis. In 2025, Samsung Bioepis was spun off from Samsung Biologics, to establish a new investment holdings company Samsung Epis Holdings, which has 100% ownership in Samsung Bioepis and Epis NexLab.

Samsung Bioepis has developed one of the most expansive and rapidly growing biosimilars portfolios in the industry, opening up access to 11 life-changing and life-saving medicines worldwide in immunology, oncology, ophthalmology, endocrinology, hematology, nephrology, and neurology. Beginning with its first biosimilar approval in the US for Renflexis^® [infliximab-abda] in 2017, to its most recent FDA approval for Ospomyv^® and Xbryk^™ [denosumab-dssb], Samsung Bioepis has 10 biosimilars approved by the Food and Drug Administration (FDA). In the US, Samsung Bioepis commercializes its seven biosimilars through partnerships with several major pharmaceutical companies, including Cordavis, Harrow, Organon, Sandoz, and Teva.

Based in Incheon, South Korea, Samsung Bioepis is led by Kyung-Ah Kim, President and Chief Executive Officer. The company’s global commercial efforts are overseen by Linda Choi MacDonald, Executive Vice President and Global Head of Commercial.

The company’s presiding leadership in the US are Thomas Newcomer, Senior Vice President and Head of US Commercial. Gillian Woollett provides science-based regulatory strategy and policy expertise as Vice President and Head of Regulatory Strategy and Policy, in support of a globally harmonized approach.

There is a central Samsung philosophy throughout all Samsung affiliates: to devote the company’s talent and technology to create best-in-class products and services that contribute to a better global society. For Samsung Bioepis, this has been translated into a mindset that allows the company to develop biosimilars in the most efficient, yet rigorous way possible, so that quality is maintained from lab-scale development to commercial-scale manufacturing.

The company’s mission is to find smarter, faster ways of delivering quality-assured medicines to people who need them and transform the way biologic therapies are brought to patients. Their mission is reflected in the name, bio-epis; meaning life (“bio”) and science (“episteme”) in Greek. Samsung Bioepis seeks to enhance the lives of patients through the pioneering and innovative use of science and technology.

Why you may be hearing more about Samsung Bioepis:

Samsung Bioepis is researching and developing medicines to meet unmet needs due to access and affordability challenges. Our biosimilars offer competition to high-cost, high-value biopharmaceuticals, and this includes orphan, rare disease areas where patients around the world have limited access to treatments.

The heart of Samsung Bioepis’ biosimilar pipeline is the next generation of biosimilars for oncology as well as other therapeutic areas: SB27 is its marquee biosimilar candidate for pembrolizumab (Keytruda), which has ongoing Phase 1 and Phase 3 clinical studies. In addition to SB27, the company has multiple biosimilar candidates in early-stage development, with a goal to secure more than 10 biosimilars in the development pipeline by 2030.

Samsung Bioepis is uniquely prepared for success in today’s biosimilar industry. The company has been at the forefront of innovating access to biologics by delivering clinically-proven, quality-assured biosimilars through globally diversified manufacturing and supply chain network.

The company ensures consistent quality in every step of development, manufacturing, and supply process; only the highest-quality candidates that meet the tight quality specifications progress to the next stage of development. Manufacturing processes are monitored and managed stringently to minimize batch-to-batch variability. Using high-precision, state-of-the-art technologies to assess the critical quality attributes of a biologic molecule, the company uses up to 80 methods to analyze its biologic activity, purity, immunologic properties, and physiochemical characteristics.

Samsung Bioepis also aims to ensure 100% supply continuity to patients by strategically partnering across Europe, North America, and Asia. This has resulted in more than 85 million units supplied across more than 40 countries without major supply disruptions.

The company continues to champion policy changes like streamlining biosimilar development, and is a vocal participant in the FDA’s discussions in harmonizing the global biosimilar development requirements based on the solid real-world evidence acquired to date.

(January 27, 2026) Stakeholders across the US health care system navigated a maturing biological market that reached a significant milestone of 90 total approvals by the end of 2025. This progress, detailed in a recent industry report from Samsung Bioepis, highlighted how the biosimilar sector moved beyond early-stage growth into a complex era of high market penetration and shifting financial incentives.

(January 16, 2026) For biosimilar industry watchers like BR&R, Samsung Bioepis has played a leading role in introducing biosimilars to the US market. On January 15, Samsung Epis Holdings, the parent of Samsung Bioepis, announced a healthy new slate of biosimilar candidates in early-stage development.

(January 8, 2026) The promise of broad biosimilar adoption and lower drug prices hasn’t played out as initially anticipated, leaving the biosimilar market at a critical inflection point as it enters 2026, with policy changes and major patent cliffs creeping ever closer. One key priority is building awareness, says Thomas Newcomer, VP and head of US commercial operations at Samsung Bioepis.

(December 8, 2025) Gillian Woollett, VP and Head of Regulatory Strategy at Samsung Bioepis, discusses how the current regulatory climate is the result of years of work—30 years of comparability and 20 years of biosimilars.

(November 5, 2025) Samsung Epis Holdings announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis from Samsung Biologics.

(September 1, 2025) Currently, 90% of the 118 biologics losing exclusivity in the next decade have no biosimilar candidates in development—a phenomenon known as the “biosimilar void.” The sustainability of the biosimilar market is at risk without sufficient biosimilar competition, according to Samsung Bioepis.

(July 17, 2025) On July 17th, Samsung Bioepis announced that its search for a new ophthalmology partner was over: It had entered a new license, development, and commercialization agreement with Harrow for two of its ophthalmology biosimilars.

(April 7, 2025) Epysqli will be offered at a 30% discount of the wholesale acquisition cost of the reference product, Soliris. Teva will market Samsung Bioepis’ eculizumab biosimilar in the US.

(February 17, 2025) The FDA approved Samsung Bioepis’ biologics license application for SB16, its denosumab biosimilar candidate. Dubbed Ospomyv for the treatment of postmenopausal women with osteoporosis (reference product Prolia), and Xbryk (denosumab-dssb) for the treatment of bone complications of oncology disorders (reference product Xgeva).

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