Samsung Bioepis Co., Ltd.

Samsung Bioepis Co., Ltd. is a biopharmaceutical company headquartered in Songdo, Incheon, South Korea, dedicated to increasing patient access to high-quality medicines. The company's core mission is to broaden access to life-changing biologic therapies by developing and commercializing biosimilars. Established in 2012, Samsung Bioepis aims to become a leading global biopharmaceutical entity by making healthcare more accessible through product development innovations and a commitment to quality.

Samsung Bioepis focuses on a broad pipeline of biosimilar candidates across various therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Its portfolio includes 11 approved biosimilars, with examples such as those referencing Etanercept (Enbrel), Infliximab (Remicade), Adalimumab (Humira), Trastuzumab (Herceptin), Bevacizumab (Avastin), Ranibizumab (Lucentis), Eculizumab (Soliris), Ustekinumab (Stelara), and Aflibercept (Eylea). The company is also involved in novel drug development and has shifted towards an integrated development and commercialization model, encompassing direct sales and strategic partnerships to manage distribution.

In late 2025, Samsung Bioepis underwent a significant corporate restructuring, spinning off from Samsung Biologics to become a wholly-owned subsidiary of the newly formed Samsung Epis Holdings Co., Ltd. Samsung Epis Holdings was subsequently listed on the Korea Exchange (KRX) on November 24, 2025. Kim Kyung-ah serves as the CEO of both Samsung Bioepis and Samsung Epis Holdings. The company continues to strengthen its development capabilities, aiming for a portfolio of over 20 biosimilars. Recent market activities include the launch of Opuviz (an aflibercept biosimilar) across Europe and an ustekinumab biosimilar in Japan in May 2026, followed by the launch of PYZCHIVA (ustekinumab biosimilar) in Canada in June 2026. Samsung Bioepis reports significant market share gains for its biosimilars, particularly in oncology and supportive care, driven by aggressive pricing strategies that contribute to substantial healthcare savings.