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Samsung Bioepis

A South Korean biosimilar powerhouse with 11 approved products across more than 40 countries, now extending its reach into antibody-drug conjugates and novel biologics while posting record revenues.

Company Overview

A South Korean biosimilar powerhouse with 11 approved products across more than 40 countries, now extending its reach into antibody-drug conjugates and novel biologics while posting record revenues. Samsung Bioepis was established in 2012 and its name draws on the Greek roots for life and science. It operates across immunology, oncology, ophthalmology, hematology, nephrology, neurology and endocrinology. The company posted full-year 2025 revenue of KRW 1.672 trillion, a record high, with underlying product-sales operating profit up 101% once milestone distortions are stripped out.

Headquarters and Global Presence

Samsung Bioepis is headquartered at 107 Cheomdan-daero, Yeonsu-gu, Incheon, South Korea. Its commercial footprint spans more than 40 countries through a network of regional distribution and co-commercialization partners. Samsung Epis Holdings, the parent entity, established a China R&D Center in 2026, signaling an active push into one of biosimilars' most contested growth markets.

Founding and History

Samsung Bioepis was founded in 2012 as a joint venture between Samsung Biologics and Biogen, with early partnership agreements signed with Merck & Co and Biogen in 2013. Biogen sold its 49.9% equity stake to Samsung Biologics for aggregate consideration of up to $2.3 billion, with the transaction closing in April 2022. In November 2025, Samsung Biologics completed a spin-off of its investment and subsidiary management operations, creating Samsung Epis Holdings as a separately listed entity; Samsung Bioepis now operates as a wholly owned subsidiary of Samsung Epis Holdings.

Therapy Areas and Focus

Immunology and oncology anchor the commercial portfolio, with autoimmune conditions spanning psoriasis, Crohn's disease and psoriatic arthritis representing the largest revenue base. Ophthalmology biosimilars targeting neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion form a growing second pillar. The company is deliberately broadening beyond biosimilars: the SBE303 antibody-drug conjugate program marks its first foray into novel oncology therapeutics. A collaboration with G2GBIO and Epis NexLab to develop long-acting semaglutide adds endocrinology to the strategic horizon.

Technology Platforms and Modalities

The established foundation is monoclonal antibody and fusion-protein biosimilar development, where the company has built a track record across IgG1, IgG4 and VEGF-trap molecule types. For its ADC program, Samsung Bioepis licenses IntoCell's proprietary linker-payload technology, applied across up to five candidates with SBE303 as the lead. A research collaboration with Proteina targets AI-based antibody therapeutic design, and the G2GBIO agreement brings sustained-release microsphere formulation capabilities into the portfolio. These partnerships signal a deliberate shift from molecule replication toward differentiated biologic innovation.

Key Pipeline and Programs

SB17 is a ustekinumab biosimilar referencing Stelara, a human IgG1 kappa monoclonal antibody that binds the p40 subunit shared by IL-12 and IL-23. It is approved and marketed as PYZCHIVA in the EU, UK and US, as EPYZTEK in Korea, and has received two separate Japanese approvals: the 45 mg subcutaneous syringe for plaque psoriasis and psoriatic arthritis cleared in December 2025, and the 130 mg intravenous formulation for moderate-to-severe active Crohn's disease approved September 3, 2026. Stelara is one of the largest biologics to lose exclusivity, making this one of biosimilars' most commercially significant targets.

SB27 is a proposed biosimilar to Keytruda (pembrolizumab), the checkpoint inhibitor that anchors oncology regimens across multiple tumor types. Phase I pharmacokinetic equivalence and Phase III objective response rate equivalence at Week 24 were both confirmed, with primary endpoints met in both studies as of mid-2026. Regulatory submissions have not yet been announced, but the clinical package is complete enough to support filing.

SBE303 is Samsung Bioepis's first novel drug candidate: a Nectin-4-targeting antibody-drug conjugate using IntoCell's linker-payload technology, designed for urothelial, lung and breast cancers where Nectin-4 is overexpressed. A commercial license agreement with IntoCell was signed July 22, 2026 and the program entered a first-in-human Phase I trial in advanced refractory solid tumors in March 2026. The IntoCell collaboration covers up to five ADC candidates in total.

Recent Developments

On October 1, 2026 Samsung Bioepis and Teva agreed a global license, development and commercialization deal for up to six biosimilar candidates, two of them named: SB41, referencing AstraZeneca's Fasenra (benralizumab), and SB44, referencing Novartis' Ilaris (canakinumab). No financial terms were disclosed. The September 3, 2026 Japanese approval of the ustekinumab IV formulation for Crohn's disease was the second regulatory win in Japan under the NIPRO partnership and is scheduled for National Health Insurance listing and patient availability in November 2026. In August 2026 Samsung Bioepis launched the OPUVIZ pre-filled syringe across Europe, following the May 2026 vial launch, after settling patent disputes with both Regeneron (US) and Regeneron/Bayer (rest of world) earlier in the year. The SB27 pembrolizumab biosimilar met primary endpoints in both Phase I and Phase III as of June 2026, while SBE303 entered global Phase I in March 2026. First-half 2026 revenue reached KRW 847.1 billion, up 6% year over year.

Key Personnel

Kyung-Ah Kim serves as president and chief executive, having signed the company's corporate letter and been cited in multiple 2026 deal and results announcements. Linda Choi MacDonald serves as executive vice president and global head of commercial. Antonio Rito serves as vice president and head of Europe, and was cited at the OPUVIZ pre-filled syringe European launch in August 2026.

Strategic Partnerships

In Japan, NIPRO CORPORATION holds marketing authorization and handles commercial distribution for the ustekinumab biosimilar portfolio under a multi-product agreement signed June 2025. US distribution for the ophthalmology biosimilars BYOOVIZ and OPUVIZ transferred to Harrow in July 2025, after Biogen terminated the original 2019 agreement; European rights for both products reverted to Samsung Bioepis under an asset purchase agreement with Biogen completed at end-2025. Sandoz holds a global license, development and commercialization agreement covering up to five biosimilar candidates including SB36, a vedolizumab biosimilar, signed in March 2026. Teva, which already sells the eculizumab biosimilar Epysqli in the US and holds Canadian rights to OPUVIZ, became a global partner in October 2026 under a license covering up to six biosimilar candidates: Samsung Bioepis develops, registers and manufactures them, and Teva commercializes them in the US, Europe and Canada. Organon holds Canadian rights to PYZCHIVA; additional regional partners include Cordavis and Sandoz in the US. The IntoCell collaboration, running since December 2023, provides the linker-payload technology underpinning the ADC pipeline. A 2026 partnership with Proteina targets AI-driven antibody therapeutic development.

FAQ Section

The biosimilar business is maturing and pricing pressure intensifies as more competitors enter each reference-product class. SBE303, the Nectin-4 ADC entering Phase I in 2026, represents a deliberate attempt to build a novel-drug revenue layer before the biosimilar growth curve flattens. CEO Kyung-Ah Kim described the IntoCell commercial license as "an important milestone in the continued expansion of our pipeline beyond biosimilars," and the IntoCell collaboration covers up to five ADC candidates in total.

Stelara is one of the largest biologics targets available to biosimilar developers. The molecule's dual IL-12/IL-23 p40 inhibition gives it approved utility across psoriasis, psoriatic arthritis and Crohn's disease, three separate patient populations with distinct payer and prescriber dynamics. Samsung Bioepis now has both subcutaneous and intravenous presentations approved in Japan, meaning it can address induction therapy in Crohn's as well as maintenance dosing across indications.

The company competes on commercial breadth rather than first-mover advantage: ten US-approved biosimilars across immunology, oncology, ophthalmology and bone metabolism give it a negotiating scale that most biosimilar specialists cannot match. It also operates its own direct European commercialization capability following the 2025-2026 buy-back of ophthalmology rights from Biogen, reducing dependency on third-party distributors in a key market. The shift into ADC development and AI-antibody programs through Proteina adds a differentiation layer that pure biosimilar manufacturers have not yet pursued.

SB27 is a proposed biosimilar to Keytruda (pembrolizumab), the PD-1 checkpoint inhibitor that is the world's best-selling oncology drug. Phase I pharmacokinetic equivalence and Phase III objective response rate equivalence at Week 24 were both confirmed as of mid-2026, meaning the clinical data package needed to support a biosimilar submission is substantially complete. No filing date has been publicly announced, but the program is the most advanced in Samsung Bioepis's late-stage oncology biosimilar portfolio.

Immunology, led by the ustekinumab and adalimumab franchises, generates the largest share of revenue. Ophthalmology is the fastest-moving commercial segment: BYOOVIZ and OPUVIZ are now direct-commercialized across Europe and partnered with Harrow in the US. Bone metabolism and oncology round out the portfolio, with denosumab biosimilars OSPOMYV and XBRYK recently expanded in the US and Europe. A semaglutide long-acting program in collaboration with G2GBIO and Epis NexLab indicates endocrinology will be the next territory the company enters.

The company is fully commercial, with 11 biosimilars approved and revenue of KRW 1.672 trillion in 2025. The near-term catalysts are the November 2026 Japanese NHI listing for the ustekinumab IV product, a regulatory submission for SB27 once the company chooses its filing markets, and Phase I dose-escalation data from SBE303. On the commercial side, integration of directly managed European ophthalmology launches and the Sandoz vedolizumab collaboration progressing toward a filing are the key operational milestones to monitor.

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