Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030
The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies
Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this year
Samsung Bioepis plans to add one novel therapeutic candidate in clinical study every year

Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114206458/en/

Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings

"2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.”

Samsung Bioepis Biosimilar Updates

Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries.¹ The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030.
The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

Novel Therapeutics Updates

In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer.² The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.
Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year.
Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.

Samsung Bioepis Biosimilars Portfolio

Code Name (Brand Name³)	Non-proprietary Name	Reference Product	Status⁴
SB5 (IMRALDI™, HADLIMA™, ADALLOCE™)	Adalimumab	Humira	Launch
SB4 (BENEPALI™, BRENZYS™, ETOLOCE™)	Etanercept	Enbrel	Launch
SB2 (FLIXABI™, RENFLEXIS™, REMALOCE™)	Infliximab	Remicade	Launch
SB3 (ONTRUZANT™, SAMFENET™)	Trastuzumab	Herceptin	Launch
SB8 (AYBINTIO™)	Bevacizumab	Avastin	Launch
SB11 (BYOOVIZ™, AMELIVU™)	Ranibizumab	Lucentis	Launch
SB12 (EPYSQLI™)	Eculizumab	Soliris	Launch
SB15 (OPUVIZ™, AFILIVU™)	Aflibercept	Eylea	Launch
SB16 (OBODENCE™, OSPOMYV™)	Denosumab	Prolia	Launch
SB16 (XBRYK™)	Denosumab	Xgeva	Launch
SB17 (PYZCHIVA™, EPYZTEK™)	Ustekinumab	Stelara	Launch
SB27	Pembrolizumab	Keytruda	Phase 1 and 3

Samsung Bioepis Biosimilar Candidates in Early Stage Development

Non-proprietary Name	Reference Product
Dupilumab	Dupixent
Guselkumab	Tremfya
Ixekizumab	Taltz
Vedolizumab	Entyvio
Ocrelizumab	Ocrevus
Fam-trastuzumab deruxtecan-nxki	Enhertu

About Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: www.samsungepisholdings.com.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Epis NexLab Co., Ltd.

Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: www.samsungepisholdings.com.

¹ “more than 40 countries” signifies countries where Samsung Bioepis has commercial presence, with one or more products.
² Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101.
³ Different brand names for different regions and countries.
⁴ “Launch” signifies launch in one or more markets and does not necessarily indicate launch in all markets worldwide

View source version on businesswire.com: https://www.businesswire.com/news/home/20260114206458/en/

Media Contact
Anna Nayun Kim, nayun86.kim@samsung.com
Yoon Kim, yoon1.kim@samsung.com

Logo

Images

Tags

More Like This

Samsung Bioepis Enters into Partnership Agreement with Sandoz for Up to Five Next-Generation Biosimilar Candidates

Samsung Bioepis Initiates Phase 1 Clinical Trial for SBE303, Nectin-4 Targeting Antibody-Drug Conjugate (ADC) Candidate

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

Newly Established Samsung Epis Holdings to Drive Growth for Samsung Bioepis and a New Subsidiary

Samsung Bioepis Reaches Settlement Agreement for PYZCHIVA® (ustekinumab) in Europe

CORRECTING and REPLACING Samsung Epis Holdings Reports First Quarter 2026 Financial Results

Samsung Bioepis Begins Commercialization of BYOOVIZ®, Biosimilar to Lucentis (Ranibizumab), in Europe

Samsung Bioepis to Commercialize BYOOVIZ® (ranibizumab) in Europe from January 2026