Samsung Bioepis Brand Guidelines: A 2012 Biogen Venture, Benepali & the 2025 Spin-Off

A Samsung and Biogen joint venture.

Samsung Bioepis is a biosimilar developer based in Incheon, South Korea; its website lists sites at Songdo, in Incheon, and at Suwon. Korean Wikipedia gives its start as 28 February 2012, when Samsung Biologics, the Samsung group’s contract manufacturer, and the American biotechnology company Biogen Idec, now Biogen, launched it as a joint venture for the research, development and commercialisation of biopharmaceuticals. Its present parent, Samsung Epis Holdings, gives the same establishment date.

The company explains its name in its own words: “bio-epis,” it says, means life, from “bio,” and science, from the Greek “episteme.” It says it opened its R&D centre in its first year and signed partnerships with Merck & Co. and with Biogen in 2013; its history adds that the Merck partnership now runs with Organon, which was spun off from Merck in June 2021.

Korean Wikipedia places the venture inside the Samsung group’s strategy. After semiconductors, it says, the group has treated biotechnology as a new engine of growth, with two companies leading it: Samsung Bioepis, developing biosimilars, and Samsung Biologics, running the contract-manufacturing business. The Korea Times reported in November 2025 that clients of Samsung Biologics had raised concerns about potential conflicts of interest as Samsung Bioepis widened its work beyond biosimilars into new drugs, including antibody-drug conjugates.

Benepali first in Europe.

Its first approvals came in Korea in 2015, for biosimilars of infliximab and etanercept, the company says. Europe followed in 2016. The European Medicines Agency’s record gives 13 January 2016 as the date the marketing authorisation was issued for Benepali, its etanercept biosimilar, and English Wikipedia notes that Biogen released Flixabi, an infliximab biosimilar that appears among the products named on the Samsung Bioepis website. In the United States, the company records its first FDA approval, for infliximab, in 2017.

The range grew quickly from there, by the company’s own dates: biosimilars of adalimumab and trastuzumab approved in Europe in 2017 — the EMA gives 15 November 2017 for the trastuzumab biosimilar Ontruzant, held by a Samsung Bioepis company in the Netherlands — then bevacizumab in Europe in 2020 and ranibizumab in Europe and the US in 2021. In 2023, it says, its ranibizumab biosimilar was approved as interchangeable by the FDA, and biosimilars of eculizumab, aflibercept, ustekinumab and denosumab followed between 2023 and 2025. The company says eleven of its biosimilars are sold in more than 40 countries, through commercial partners and its own network.

Its partners have changed over time. The company lists a partnership with Sandoz in 2023 and with Teva and Harrow in 2025. Its pipeline, last updated in October 2026 according to its website, includes candidates such as SB27, a pembrolizumab biosimilar, and novel medicines such as SBE303, an antibody-drug conjugate that the company says entered a phase I trial and received FDA fast-track designation in 2026.

Its own milestones are not only approvals. The company lists the opening of a new headquarters in 2021, and its history records an FDA approval in 2022 for a citrate-free, high-concentration version of its adalimumab biosimilar. In 2026, it says, Samsung Epis Holdings set up a research and development centre in China, and Samsung Bioepis signed partnerships with Samsung Medical Center and with Proteina, for drug development using artificial intelligence.

Design and documentation.

Biosimilar makers sell medicines that most people only ever meet as a pack in a pharmacy or a hospital ward, so their public image is built from the places where those medicines are made. Their websites and reports favour gleaming steel bioreactors, vials moving along blue-lit filling lines, scientists in gowns and hoods, and close-ups of prefilled syringes and autoinjector pens. The pictures signal scale and control rather than any single product.

The category is young. The European Medicines Agency’s record shows that the marketing authorisation for Celltrion’s Remsima, a biosimilar of the antibody infliximab, was issued on 10 September 2013, and English Wikipedia describes it as the first biosimilar monoclonal antibody approved by the EMA. Since then a group of companies in Asia, Europe and North America has built ranges of biosimilars, each sold under a brand name of its own, alongside the corporate names covered in this guide.

Their messaging leans on access. Celltrion states a mission of “a healthier tomorrow where no patients are left untreated”; Samsung Bioepis says it makes “quality-assured biologic medicines more accessible, more quickly.” Celltrion’s brand page ties its green to trust. Trade meetings such as the GRx+Biosims conference and the BIO International Convention are where the sector’s companies present their pipelines and meet partners.

This guide sets out what can be checked about each maker — who founded it, who owns it, and which approvals and deals dated sources record — and marks clearly what rests only on the company’s own word.

From joint venture to listed holding.

Ownership has changed twice. In January 2022 Samsung Biologics agreed to buy Biogen’s 49.9 percent stake in the joint venture, Asia Financial reported, quoting Biogen’s chief executive thanking Samsung Biologics for “a productive collaboration since 2012.” Korean Wikipedia says the purchase was completed in April 2022, ending about four years of joint management and making Samsung Bioepis a wholly owned subsidiary of Samsung Biologics.

The second change came in 2025. Samsung Biologics announced in May that it would split off the business that managed its subsidiary and new investments. In a release dated 3 November 2025 it said the spin-off had been finalised on 1 November, after shareholders approved it on 17 October, creating Samsung Epis Holdings. The Korea Times reported that the new holding company took over the whole of Samsung Bioepis and made its debut on the KOSPI market on 24 November 2025, completing the separation. Samsung Epis Holdings says it now has two subsidiaries, Samsung Bioepis and Epis NexLab, a new company working on peptide-related platform technologies, and that it aims to make Samsung Bioepis the “world’s No. 1 biosimilar company.” Kyung-Ah Kim leads both the holding company and Samsung Bioepis, the companies say.

The brand rests on two words: the Samsung group name and a coined word that joins life and knowledge. The palette here is our own.

For a design guide, Samsung Bioepis shows how a joint venture can grow into a listed group of its own while keeping a parent’s name. Compare Samsung Biologics, its former parent, and Sandoz, one of its commercial partners. For this guide we use a navy, a night ink and a haze blue with a serif, an unofficial interpretation; no product or logo is reproduced.

Keep Samsung Bioepis’s identity on hand — save it to a board in the Made Good inspiration library.