Samsung Bioepis

What Samsung Bioepis does

Samsung Bioepis is a South Korean biopharmaceutical company founded in 2012 that develops, manufactures, and commercializes biosimilars across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. The company's portfolio includes 11 approved biosimilars — including HADLIMA (adalimumab), PYZCHIVA (ustekinumab), ONTRUZANT (trastuzumab), AYBINTIO (bevacizumab), BYOOVIZ (ranibizumab), OPUVIZ (aflibercept), EPYSQLI (eculizumab), and OBODENCE/XBRYK (denosumab) — marketed across 40+ countries referencing blockbusters such as Humira, Stelara, Herceptin, Avastin, Lucentis, Eylea, Soliris, and Prolia/Xgeva. Its core technology platform encompasses mammalian cell culture, purification processes, and analytical/bioassay methods for demonstrating biosimilarity; the company is now extending into novel modalities including a Nectin-4-targeting antibody-drug conjugate (SBE303, Phase 1) and long-acting GLP-1 formulations via G2GBIO's microsphere technology.

The company operates a hybrid commercialization model: direct sales of five products in Europe since 2023, complemented by exclusive regional partnerships — Sandoz (global ex-Asia), Organon (Canada), NIPRO (Japan), Harrow (US ophthalmology), and Teva (US EPYSQLI). Revenue is generated through biosimilar product sales, licensing and milestone payments, and co-development arrangements. Samsung Bioepis is a wholly owned subsidiary of Samsung Epis Holdings, which was spun off from Samsung Biologics in November 2025 and listed on the Korea Exchange, providing access to Samsung Group's manufacturing scale, capital, and global network. The company employs 501-1,000 staff at its Songdo headquarters, with average employee age of 34, and is establishing additional R&D capabilities including a new Beijing R&D center opened June 2026.

Name

Samsung Bioepis

Legal name

Samsung Bioepis Co., Ltd.

Website

https://samsungbioepis.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

501–1,000 employees

Short description

Samsung Bioepis is a South Korean biopharmaceutical company that develops, manufactures, and commercializes biosimilars across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology in 40+ countries, using direct European sales and global partner channels, and is now expanding into novel antibody-drug conjugates and long-acting biologics.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals (Biosimilars)

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Inflammation Biosimilars (HLAAAHAF)

akta.pro secondary industries

Anti-TNF Biosimilars (HLAIAFAE), Oncology Biosimilars (HLAAAHAG), Ophthalmology Biosimilars (HLAAAHAH), Recombinant Protein Biosimilars (hormones, enzymes, cytokines) (HLAAAHAB)

Keywords

• Biosimilar development
• Biopharmaceutical products
• Antibody drug conjugates
• Biologics manufacturing
• Clinical research services

Headquarters

HQ city

Incheon

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Biosimilar Product Sales: Revenue from direct sales of biosimilar products in Europe and through partnerships globally. Products include adalimumab, ustekinumab, aflibercept, ranibizumab, denosumab, eculizumab biosimilars marketed under various brand names.
2. Partnership and Milestone Payments: Revenue from development, regulatory, and commercialization milestones under partnerships with Sandoz, Organon, Teva, NIPRO, Harrow, and others. Also includes technology transfer and licensing fees.
3. Co-development Revenue: Revenue from collaborative R&D arrangements including open innovation programs, joint ventures, and shared development costs with partners.

Go-to-market motion2 records

Distribution channels6 records

Marketing channels6 records

Core offering

Samsung Bioepis develops, manufactures, and commercializes biosimilar medicines across immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology therapeutic areas. The portfolio includes 11 approved biosimilars referencing blockbusters such as Humira, Enbrel, Remicade, Stelara, Lucentis, Eylea, Soliris, Prolia/Xgeva, Avastin, and Herceptin. The company also develops novel biologics including the SBE303 antibody-drug conjugate targeting Nectin-4 and a long-acting semaglutide program.

Product overview

Samsung Bioepis is a biopharmaceutical company focused on developing, manufacturing, and commercializing biosimilars — biologics highly similar to FDA/EMA-approved reference products with no clinically meaningful differences in safety, purity, and efficacy. The company's portfolio includes multiple approved biosimilars across therapeutic areas including immunology (HADLIMA, BRENZYS, RENFLEXIS, PYZCHIVA), oncology (AYBINTIO, ONTRUZANT), ophthalmology (OPUVIZ, BYOOVIZ), hematology/nephrology (EPYSQLI), and endocrinology (OBODENCE/XBRYK). The company also has novel drug candidates in development, including SBE303, a Nectin-4 targeting antibody-drug conjugate for oncology. Samsung Bioepis operates as a wholly owned subsidiary of Samsung Epis Holdings and partners with global pharmaceutical companies including Sandoz, Organon, Teva, NIPRO, and Harrow for commercialization across various markets.

Differentiator

Problem solved

Functional benefit

Brands

• Re:Access: Newsletter series by Samsung Bioepis that Rethinks biosimilars as the answer to future healthcare Access.
• C-Lab Outside
• AI Academy

Products and services

• HADLIMA (Adalimumab biosimilar) Biosimilar referencing Humira (adalimumab) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Marketed by Samsung Bioepis through partners including Organon.
• BRENZYS (Etanercept biosimilar) Biosimilar referencing Enbrel (etanercept) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Marketed by Samsung Bioepis through partners including Organon.
• RENFLEXIS (Infliximab biosimilar) Biosimilar referencing Remicade (infliximab) for the treatment of autoimmune conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, and psoriasis. Marketed by Samsung Bioepis through partners including Organon.
• PYZCHIVA / SB17 / EPYZTEK (Ustekinumab biosimilar) Biosimilar referencing Stelara (ustekinumab) for the treatment of autoimmune diseases including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Approved in EU, UK, US, and Japan. Marketed under brand names PYZCHIVA in EU/UK/US, EPYZTEK in Korea, and through NIPRO in Japan.
• AYBINTIO (Bevacizumab biosimilar) Biosimilar referencing Avastin (bevacizumab) for the treatment of various cancers including metastatic colorectal cancer, non-small cell lung cancer, and other malignancies. Marketed by Samsung Bioepis through partners including Organon.
• ONTRUZANT (Trastuzumab biosimilar) Biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast cancer and gastric cancer. Marketed by Samsung Bioepis through partners including Organon.
• OPUVIZ / AFILIVU (Aflibercept biosimilar) Biosimilar referencing Eylea (aflibercept) for the treatment of ophthalmic conditions including neovascular age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. Approved by FDA May 2024 and European Commission November 2024.
• BYOOVIZ (Ranibizumab biosimilar) Biosimilar referencing Lucentis (ranibizumab), the first FDA-approved ophthalmology biosimilar (approved by European Commission August 2021), for the treatment of neovascular age-related macular degeneration and diabetic eye conditions.
• EPYSQLI (Eculizumab biosimilar) Biosimilar referencing Soliris (eculizumab) for the treatment of rare diseases including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Commercialized in the US by Teva Pharmaceuticals since April 2025 and directly in Europe.
• OBODENCE / XBRYK / OSPOMYV (Denosumab biosimilar) Biosimilar referencing Prolia/Xgeva (denosumab) for the treatment of osteoporosis and bone metastases. Marketed as OBODENCE/XBRYK in Europe, OSPOMYV in the United States, and under other names in additional markets. Approved by FDA in February 2025 and by the European Commission.
• SB27 (Pembrolizumab biosimilar candidate) Proposed biosimilar to Keytruda (pembrolizumab) currently in Phase 1 and Phase 3 clinical trials. Phase 1 demonstrated pharmacokinetic bioequivalence in 163 patients with resected non-small cell lung cancer. Being developed under the global partnership with Sandoz.
• SB36 (Vedolizumab biosimilar candidate) Proposed biosimilar to Entyvio (vedolizumab) targeting inflammatory bowel diseases including Crohn's disease, ulcerative colitis, and pouchitis. In pre-clinical development under the global Sandoz partnership.
• SBE303 (Nectin-4 targeting ADC) First novel antibody-drug conjugate (ADC) candidate engineered to target Nectin-4, an adhesion protein specifically expressed in tumor cells including urothelial cancer, lung cancer, and breast cancer. Combines a highly specific anti-Nectin-4 antibody with a potent novel topoisomerase I inhibitor via a proprietary linker. Currently in Phase 1 clinical trials.

Quantifiable outcome

• $56 billion saved for US stakeholders due to biosimilar entrants over the past decade
• +4 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• OrganoncoreChannel Partner/ Reseller/ Distributor · 18 June 2026Expanded agreement granting Organon exclusive commercialization rights in Canada for PYZCHIVA (ustekinumab biosimilar). Expands portfolio from five to six biosimilars in Canada across immunology, oncology, and dermatology. Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities. Expected to launch 2026.
• Samsung Medical CenterminorStrategic or Co-development Partner · 1 June 2026Joint research agreement for AI-driven drug research. Establishes consultative body and research advisory committee to carry out collaborative projects through 2030. Samsung Bioepis plans to leverage SMC's extensive medical data for AI-powered treatment technologies, novel drug target identification platform, and innovative therapeutics including ADC development.
• Seoul BiohubminorStrategic or Co-development Partner · 13 May 2026First open innovation initiative aimed at fostering AI and antibody drug startups in South Korea.
• ATLATL Innovation CenterminorStrategic or Co-development Partner · 29 April 2026MoU for open innovation program to accelerate early-stage biotech innovation in Asia-Pacific. Selected startups gain access to ATLATL's incubation centers in Beijing, Shanghai, Shenzhen, Singapore, Hong Kong, and Australia. Samsung Bioepis launched Innovation Prize C-Lab Outside program through this partnership targeting oncology, immunology, inflammation, and metabolic diseases.
• SandozcoreChannel Partner/ Reseller/ Distributor · 18 March 2026Global partnership to develop and commercialize up to five biosimilar candidates including SB36 (vedolizumab biosimilar). Samsung Bioepis handles development, regulatory registration, and manufacturing. Sandoz handles commercialization globally excluding China, Hong Kong, Taiwan, Macau, and South Korea. Builds on existing PYZCHIVA partnership established September 2023.
• G2GBIOminorStrategic or Co-development Partner · 16 March 2026Research collaboration and license agreement for long-acting semaglutide drug candidates using G2GBIO's proprietary microsphere technology for sustained-release formulations. Samsung Bioepis receives full licensing rights to long-acting semaglutide asset and options for additional assets. Samsung Epis Holdings invested 20 billion won in convertible bonds.
• Regeneron and BayercoreStrategic or Co-development Partner · 11 February 2026Settlement for Eylea biosimilar Opuviz allowing Samsung to launch in US January 2027. Joint stipulation filed February 11, 2026 dismissed all claims without prejudice and vacated preliminary injunction.
• RegeneroncoreStrategic or Co-development Partner · 30 January 2026Settlement and license agreement for commercialization of OPUVIZ (aflibercept biosimilar) in US (launch January 2027) and Europe/Rest of World. Resolves all patent-related disputes concerning aflibercept biosimilar program.
• HarrowcoreChannel Partner/ Reseller/ Distributor · 1 July 2025Exclusive US commercialization partnership for BYOOVIZ (ranibizumab-nuna) following return of rights from Biogen at end of 2025. Harrow assumed full commercialization responsibility entering $9 billion US anti-VEGF market. Samsung Bioepis retains responsibility for development, regulatory registration, and manufacturing.
• NIPRO CorporationcoreChannel Partner/ Reseller/ Distributor · 1 June 2025Strategic partnership for commercialization of multiple biosimilar candidates in Japan, including ustekinumab biosimilar SB17. NIPRO handles Japanese market commercialization following MHLW approval in December 2025 and NHI listing in May 2026.
• Teva PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 1 January 2025Partnership for development and commercialization of EPYSQLI (eculizumab biosimilar) for PNH and aHUS patients in the United States. Product launched April 2025.
• BeauBrain HealthcareminorChannel Partner/ Reseller/ Distributor · 1 January 2024Partnership to launch PrecivityAD2 blood test for Alzheimer's disease diagnosis in South Korea. C2N Diagnostics received $10 million investment from Samsung entities including Samsung Bioepis.

Scale indicators9 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Alvotech: Iceland-headquartered biosimilar pure-play focused on immunology, ophthalmology, and oncology. Comparable pipeline-driven business model with reliance on partners for commercialization in select markets.
• Coherus BioSciences: US-based biosimilar and immuno-oncology company with approved products including ranibizumab, pegfilgrastim, and adalimumab biosimilars. Directly comparable ophthalmology biosimilar presence (ranibizumab) overlapping with Samsung Bioepis's BYOOVIZ.
• Sandoz: Novartis's biosimilars-focused spin-off and the largest pure-play biosimilar company globally. Sandoz is both a direct competitor (Hyrimoz, Erelzi, Zessly, etc.) and Samsung Bioepis's largest commercialization partner for ex-Asia markets.
• Biocon Biologics: India-based biosimilar subsidiary of Biocon with an approved portfolio in immunology, oncology, and ophthalmology. Directly comparable product mix (trastuzumab, bevacizumab, adalimumab, etanercept biosimilars) and similar partnership-led global commercialization model.
• Celltrion: South Korea-based biosimilar pure-play with a comparable portfolio across immunology and oncology (Remsima/Inflectra, Truxima, Herzuma, etc.). Celltrion is Samsung Bioepis's closest head-to-head competitor in the global biosimilar market and shares a similar Korean origin and Asian R&D base.

Broad incumbents

• Organon: Women's health and biosimilars-focused pharma and Samsung Bioepis's exclusive Canadian commercialization partner. Overlaps as a biosimilar distributor but with a narrower geographic and therapeutic focus.
• Viatris: Global off-patent and specialty pharma company with biosimilars across immunology and oncology (HULIO, OGIVRI, HERZUMA, ABP 215). Competes in biosimilars but operates a much broader generics/specialty portfolio.
• Pfizer: Global pharma major with a sizable biosimilars portfolio acquired through Hospira (infliximab, rituximab, bevacizumab, adalimumab biosimilars). Overlaps in biosimilar category but biosimilars are a small part of Pfizer's broader innovative drug business.
• Amgen: Large originator biotech with a growing biosimilars portfolio (AMJEVITA, KANJINTI, MVASI, AVSOLA). Competes in overlapping indications but operates a much broader innovative biologic franchise rather than a biosimilar-led model.

Emerging players

• LG Chem (Life Sciences): South Korea-based chemical/pharma major with a growing biosimilars business (ranibizumab, etanercept, and other biosimilar candidates). Direct regional competitor and Korean biosimilar peer, though with a smaller approved portfolio than Samsung Bioepis.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xtwitter.com/SamsungBioepis
• LinkedInlinkedin.com/company/samsungbioepis

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Samsung Bioepis