Samsung Bioepis

Samsung Bioepis is a biopharmaceutical company focused on developing and commercializing biosimilars and novel biologics. The company, headquartered in Incheon, South Korea, was established in 2012 as a joint venture between Samsung Biologics and Biogen. In April 2022, Samsung Biologics completed the full acquisition of Samsung Bioepis for USD 2.3 billion, making it a wholly owned subsidiary. Samsung Bioepis has built a robust portfolio of biosimilars across various therapeutic areas including immunology, oncology, ophthalmology, hematology, and endocrinology. The company's product offerings include biosimilars for treatments such as Remicade (infliximab), Humira (adalimumab), and Soliris (eculizumab). In addition to biosimilars, Samsung Bioepis has expanded into the development of novel biologics, with its lead candidate SB26 (TAK-671) entering clinical trials in 2018. The company utilizes a development platform aimed at addressing cost overruns and time delays in biologics development. Samsung Bioepis has received regulatory approvals for its products in multiple markets including the US, European Union, and South Korea.

Key customers and partnerships

Samsung Bioepis has established several strategic partnerships to enhance its market presence and product development capabilities. In February 2024, the company partnered with Samil Pharmaceutical to bring its aflibercept biosimilar, SB15, to the Korean market. This partnership followed a previous agreement in June 2022 for marketing Amelivu, a ranibizumab biosimilar. Samsung Bioepis collaborates with Sandoz for the commercialization of its ustekinumab biosimilar, Pyzchiva, in Europe, the US, Canada, the European Economic Area, Switzerland, and the UK. The company has also secured a contract with the US Department of Veterans Affairs to supply its Humira biosimilar, Hadlima, to VA hospitals for a five-year period starting February 2024. In the rare disease space, Samsung Bioepis launched Epysqli, its Soliris biosimilar, in South Korea in April 2024, offering it at a significantly reduced price compared to the reference product. The company has been selling Epysqli in European countries such as Germany, France, and Italy since 2023.