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사업 개요
출처: 금융감독원 전자공시 사업보고서[ 바이오의약품 개발 및 상업화 부문 (삼성바이오에피스) ] 삼성바이오에피스는 바이오시밀러 개발 및 상업화를 중점 사업으로 자가면역질환, 종양질환, 안과질환, 혈액질환, 골질환 등 다양한 질병 영역에 걸쳐 연구 역량을 집중하고 있습니다.
2012년 회사 설립 이후 현재까지 총 11종의 바이오시밀러 제품 (레미케이드, 허셉틴, 엔브렐, 휴미라, 아바스틴, 루센티스, 솔리리스, 아일리아, 스텔라라, 프롤리아, 엑스지바의 바이오시밀러)에 대한 글로벌 상업화를 완료하였으며 한국을 비롯해 미국, 유럽, 캐나다, 호주, 브라질, 일본 등 전세계 주요 시장 내 시장 점유율을 지속적으로 확대하고 있습니다.
2025년 매출은 유형별로 바이오시밀러 제품 등 매출이 1조 6,165억원으로 96.7%, 기타 서비스 매출이 555억원으로 3.3%를 차지하였습니다. 삼성바이오에피스는 바이오시밀러 사업에서의 성과를 바탕으로 신약 개발을 신규 사업 영역으로 확대해 나가고 있습니다.
주력 분야는 항체와 독소약물이 링커로 연결되어 있는 ADC(Antibody-Drug Conjugates)로, 질병을 유발하는 인자를 정밀하게 타격할 수 있어 차세대 치료제 시장에서 각광받고 있는 모달리티입니다. 삼성바이오에피스는 2023년부터 항체 약물 접합체(ADC) 분야 연구개발에 착수하여 현재 총 2종의 신약 후보 물질 (Nectin-4 ADC, EGFR-HER3 ADC)을 포함한 파이프라인을 운영하고 있습니다.
Nectin-4 ADC는 국내 인투셀社와 공동개발 중인 혁신신약으로 2025년 12월 미국 식품의약국으로부터 임상 1상 시험계획을 승인 받았습니다. EGFR-HER3 ADC는 중국 Phrontline Biopharma社와 공동개발 계약을 체결하고 현재 전임상 진행 단계의 연구를 진행하고 있습니다.
제품 · 기술
출처: 금융감독원 전자공시 사업보고서및 서비스 당사(연결회사)의 제1기 매출은 분할기일인 2025년 11월 1일부터 12월 31일까지의 손익을 반영하고 있습니다. 당사의 연결 기준 매출은 주요 자회사인 삼성바이오에피스에서 창출되고 있으며, 이에 따라 공시 대상 사업부문 또한 단일 보고부문(바이오의약품 개발 및 상업화)으로 구성돼 있습니다. 삼성에피스홀딩스 별도회사는 지주회사로 자회사의 지배를 목적으로 하는 회사이기 때문에 제품이 존재하지 않습니다.
2025년 11월 11일 설립된 자회사 에피스넥스랩은 설립 차세대 바이오 기술 플랫폼 확보를 최우선 목표로 사업을 추진 중으로 매출이 발생하지 않았습니다. [ 바이오의약품 개발 및 상업화 부문 (삼성바이오에피스) ]
등의 가격변동 추이 삼성바이오에피스는 직접 판매 채널의 경우 시장 상황에 따라 판매 가격을 조정하는 한편, 유통사를 통한 간접 판매의 경우 유통사와의 계약에 따라 제품의 국가별 시장가격, 각종 공제항목 및 파트너사 마진을 고려하여 제품가를 산정하고 있습니다.
규제 · 인허가
공공데이터포털 · openFDA식약처 의약품 허가 20건 · 2015–2026 / 미국 FDA 의약품 승인 10건 · 2017–2025
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- FDA 약자회사 삼성바이오에피스(주)DENOSUMAB-DSSB2025-02-13FDA 의약품 승인 · BLABLA761392
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- FDA 약자회사 삼성바이오에피스(주)EPYSQLI2024-07-19FDA 의약품 승인 · BLABLA761340
- FDA 약자회사 삼성바이오에피스(주)PYZCHIVA2024-06-28FDA 의약품 승인 · BLABLA761373
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나머지 18건 보기
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- 식약처 약자회사 삼성바이오에피스(주)에피스클리주(에쿨리주맙)2024-01-19의약품 · 전문의약품 · 허가자격요법제(비특이성면역억제제를 포함)202400147
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- 식약처 약자회사 삼성바이오에피스(주)아달로체프리필드시린지주40mg/0.4mL(아달리무맙,유전자재조합)2023-01-03의약품 · 전문의약품 · 허가기타의 조직세포의 치료 및 진단202300029
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- FDA 약자회사 삼성바이오에피스(주)BYOOVIZ2021-09-17FDA 의약품 승인 · BLABLA761202
- 식약처 약자회사 삼성바이오에피스(주)온베브지주(베바시주맙)2021-03-11의약품 · 전문의약품 · 허가항악성종양제202102237
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- FDA 약자회사 삼성바이오에피스(주)ONTRUZANT2019-01-18FDA 의약품 승인 · BLABLA761100
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- 식약처 약자회사 삼성바이오에피스(주)아달로체프리필드시린지주40밀리그램(아달리무맙,유전자재조합)취소·취하2017-09-20의약품 · 전문의약품 · 허가기타의 조직세포의 치료 및 진단201707153
- FDA 약자회사 삼성바이오에피스(주)RENFLEXIS2017-04-21FDA 의약품 승인 · BLABLA761054
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연구개발 · 주요 계약
출처: 금융감독원 전자공시 사업보고서당사(삼성에피스홀딩스 별도)는 공시대상기간 중 「주요계약 및 연구개발활동」에 해당하는 사항이 없습니다. [ 바이오의약품 개발 및 상업화 부문 (삼성바이오에피스) ]
기타 계약 품목 계약상대방 계약목적, 조건 등 상세내용 계약체결일 계약종료일 계약금액 수수(지급)방법 진행경과 등 비고(판매지역) SB17(스텔라라 바이오시밀러) Cordavis Limited(이하 "Cordavis") 대상지역 내에서 공동제조한 제품의 도매 약국판매를 위한 제품의 마케팅, 판매, 제품 공급을 진행 2025.02.23 현금지급 미국 SB16(프롤리아/엑스지바바이오시밀러) Cordavis 대상지역 내에서 공동제조한 제품의 도매 약국 판매를 위한 제품의 마케팅, 판매, 제품 공급을 진행 2025.10.10 현금지급 미국 세부 내용은 영업기밀에 해당되어 기재하지 않았습니다.
연구개발 담당조직 (1) 연구개발 조직 개요 삼성바이오에피스의 연구개발은 Innovation Project, 개발본부, 임상의학본부, 생산본부에서 이루어지고 있으며 기초탐색 및 전임상, 세포주 및 공정 연구/개발, 임상의학 관련 활동, 생산 관련 기술지원 등을 담당하고 있습니다.
연구개발 실적 (1) 연구개발 진행현황 및 향후계획 공시서류 작성기준일 현재 삼성바이오에피스가 연구개발 진행 중인 신약[개량신약, 복제약(시밀러) 등 포함]의 현황은 다음과 같습니다.
논문
PubMed · 저자 소속 대조- Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026.9 · Park JP, Oh H, Woollett GR
- Precision Fc remodeling via glycosylation-competent CHO display enables ultra-selective FcγRIIIa targeting and enhanced antitumor activity.
Journal of biological engineering · 2026.4 · Jo M, Kim S, Ko S 외 5
- Analytical Data and Single-Dose PK are Sufficient to Conclude Comparable Immunogenicity for Biosimilars: An Ustekinumab Case Study.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025.9 · Schiestl M, Roy N, Trieb M 외 4
- The position of anti-tumor necrosis factor agents for the treatment of adult patients with Crohn's disease.
Expert review of gastroenterology & hepatology · 2025.7 · Hanauer SB, Duk Ye B, Cross RK 외 3
- The 'totality of evidence' and 'extrapolation' of SB17, a ustekinumab biosimilar.
Expert opinion on biological therapy · 2025.6 · Cheon JH, Duk Ye B, Armuzzi A 외 5
- Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12.
The Journal of clinical endocrinology and metabolism · 2025.5 · Langdahl B, Chung YS, Plebanski R 외 13
- Engineering FcRn binding kinetics dramatically extends antibody serum half-life and enhances therapeutic potential.
Journal of biological engineering · 2025.4 · Ko S, Jo M, Kyung M 외 6
- EPYSQLI (SB12; Biosimilar to Reference Eculizumab) in Asian and Non-Asian Patients With Paroxysmal Nocturnal Hemoglobinuria: Subgroup Analysis of a Global Phase III Randomized Controlled Trial.
EJHaem · 2025.4 · Jang JH, Tomuleasa C, Oliynyk H 외 7
- The Path to Accessible Care: Development and Impact of Eculizumab Biosimilars for Paroxysmal Nocturnal Hemoglobinuria and Atypical Hemolytic Uremic Syndrome.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025.3 · Jang JH, Han B, Jung J 외 2
- Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods.
Drugs in R&D · 2025.3 · Yang SY, Lee C, Hwang K 외 4
논문 107건 더 보기
- SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial.
Bone · 2025.3 · Chung YS, Langdahl B, Plebanski R 외 14
- Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab.
Frontiers in pharmacology · 2025.1 · Choi S, Park S, Jung J 외 2
- Long-term real-world evidence of SB5 (adalimumab biosimilar) treatment in patients with moderate-to-severe psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR).
The Journal of dermatological treatment · 2024.12 · Girolomoni G, Feldman SR, Egeberg A 외 4
- Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52.
The Journal of dermatological treatment · 2024.12 · Feldman SR, Narbutt J, Girolomoni G 외 11
- Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.
The AAPS journal · 2024.11 · Jang D, Kim J, Jo Y 외 4
- Population pharmacokinetic, pharmacodynamic and efficacy modeling of SB12 (proposed eculizumab biosimilar) and reference eculizumab.
European journal of clinical pharmacology · 2024.9 · Lee H, Park J, Jang H 외 2
- A randomized, double-blind, phase III study assessing clinical similarity of SB17 (proposed ustekinumab biosimilar) to reference ustekinumab in subjects with moderate-to-severe plaque psoriasis.
Journal of the American Academy of Dermatology · 2024.9 · Feldman SR, Narbutt J, Girolomoni G 외 11
- Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases.
Advances in therapy · 2024.8 · Lee Y, Zalewski D, Oleksy P 외 4
- Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea®).
Ophthalmology and therapy · 2024.8 · Lee H, Huh J, Kim D 외 5
- Discovery and Preclinical Activity of BMS-986351, an Antibody to SIRPα That Enhances Macrophage-mediated Tumor Phagocytosis When Combined with Opsonizing Antibodies.
Cancer research communications · 2024.2 · Chan H, Trout CV, Mikolon D 외 10
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.
Advances in therapy · 2024.2 · Kay J, Cross RK, Feldman SR 외 2
- Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review.
Survey of ophthalmology · 2024.1 · Bressler NM, Kaiser PK, Do DV 외 8
- Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis.
Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) · 2024.1 · Woo SJ, Jung JA, Kim T 외 3
- Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.
Oncology · 2024.1 · Jeon C, Kang SH, Kim SB 외 11
- Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial.
BMJ open ophthalmology · 2023.12 · Sadda SR, Bradvica M, Vajas A 외 16
- Mechanistic insights into the anti-restenotic effects of HSP27 and HO1 modulated by reconstituted HDL on neointimal hyperplasia.
Scientific reports · 2023.12 · Kim YJ, Khaleel ZH, Jin M 외 14
- In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period.
Drugs in R&D · 2023.12 · Tak M, Jeong H, Yun J 외 4
- Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.
Clinical drug investigation · 2023.8 · Corominas H, Young D, Cummings JRF 외 4
- Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.
JAMA ophthalmology · 2023.7 · Woo SJ, Bradvica M, Vajas A 외 16
- Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023.7 · Kim H, Hong E, Lee J 외 5
- Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial.
JAMA network open · 2023.4 · Pivot X, Cortés J, Lüftner D 외 17
- Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration.
Ophthalmology and therapy · 2023.4 · Kaiser PK, Yun J, Kim S 외 2
- Safety and Effectiveness of Etanercept Biosimilar SB4 for Rheumatic Diseases in South Korea: Real-World Post-marketing Surveillance Data.
Rheumatology and therapy · 2023.4 · Yoo WH, Kang YM, Kim DW 외 8
- Consistency of Product Quality for SB5, an Adalimumab Biosimilar.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023.3 · Lee JJ, Lee N, Seo YJ 외 1
- Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult Patients with Immune-Mediated Inflammatory Diseases: A Post-Marketing Surveillance in Korea.
Advances in therapy · 2023.3 · Kim DW, Lee Y, Kim G 외 7
- Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes.
The British journal of ophthalmology · 2023.3 · Bressler NM, Veith M, Hamouz J 외 16
- A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria.
EJHaem · 2023.2 · Jang JH, Gomez RD, Bumbea H 외 5
- Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial.
JAMA ophthalmology · 2023.2 · Bressler NM, Kim T, Oh I 외 3
- Development of carbon nanoparticles-based soluble solid-phase immune sensor for the quantitative diagnosis of inflammation.
Biosensors & bioelectronics · 2023.2 · Kim S, Koo M, Tak Y 외 4
- SB8, an approved bevacizumab biosimilar based on totality of evidence: scientific justification of extrapolation.
Future oncology (London, England) · 2023.2 · Peeters M, Lipp HP, Park M 외 2
- Exposure-response analysis using time-to-event data for bevacizumab biosimilar SB8 and the reference bevacizumab.
Frontiers in pharmacology · 2023.1 · Park S, Jung JA, Ju S 외 1
- NCK-associated protein 1 regulates metastasis and is a novel prognostic marker for colorectal cancer.
Cell death discovery · 2023.1 · Kwon MR, Lee JH, Park J 외 10
- The Role of PD Biomarkers in Biosimilar Development - To Get the Right Answer One Must First Ask the Right Question.
Clinical pharmacology and therapeutics · 2023.1 · Woollett GR, Park JP, Han J 외 1
- A phase I, randomized, double-blind, single-dose pharmacokinetic study to evaluate the biosimilarity of SB16 (proposed denosumab biosimilar) with reference denosumab in healthy male subjects.
Expert opinion on investigational drugs · 2023.1 · Lee HA, Kim S, Seo H 외 1
- A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar).
Rheumatology and therapy · 2022.8 · Ahn SS, Lee M, Baek Y 외 1
- Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022.7 · Park JP, Jung B, Park HK 외 6
- Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis® (Ranibizumab) Biosimilar.
Ophthalmology and therapy · 2022.4 · Kim E, Han J, Chae Y 외 5
- Epidemiology of Achilles Tendon Rupture in South Korea: Claims Data of the National Health Insurance Service from 2009 to 2017.
Clinics in orthopedic surgery · 2021.12 · Park HG, Youn D, Baik JM 외 1
- Health Economic Assessment of Optimal Biological Treatment for Moderate-to-Severe Psoriasis.
Clinical drug investigation · 2021.11 · Barker J, Baker H, Nadeem A 외 2
- Biosimilars in an era of rising oncology treatment options.
Future oncology (London, England) · 2021.10 · Peeters M, Planchard D, Pegram M 외 3
- Treatment journey in rheumatoid arthritis with biosimilars: from better access to good disease control through cost savings and prevention of nocebo effects.
RMD open · 2021.6 · Smolen JS, Caporali R, Doerner T 외 4
- Anti-tumor necrosis factor agents in psoriasis: addressing key challenges using biosimilars.
Expert opinion on biological therapy · 2021.1 · Prignano F, Choi J, Pieper B 외 1
- Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.
JAMA ophthalmology · 2021.1 · Woo SJ, Veith M, Hamouz J 외 13
- Correction to: Biologic Drug Quality Assurance to Optimize HER2+ Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3.
Targeted oncology · 2020.12 · Lüftner D, Lyman GH, Gonçalves J 외 2
- Anti-TNF biosimilars in psoriasis: from scientific evidence to real-world experience.
The Journal of dermatological treatment · 2020.12 · Barker J, Girolomoni G, Egeberg A 외 3
- Enhancing treatment success in inflammatory bowel disease: Optimising the use of anti-TNF agents and utilising their biosimilars in clinical practice.
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2020.11 · Armuzzi A, Bouhnik Y, Cummings F 외 3
- A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers.
Cancer chemotherapy and pharmacology · 2020.10 · Shin D, Lee YJ, Choi J 외 3
- Evaluation of the Physico-Chemical and Biological Stability of SB8 (Aybintio), a Proposed Biosimilar to Bevacizumab, Under Ambient and In-Use Conditions.
Advances in therapy · 2020.10 · Park D, Kim J, Yun J 외 1
- Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis.
Scandinavian journal of rheumatology · 2020.9 · Emery P, Suh CH, Weinblatt ME 외 8
- Radiographic progression based on baseline characteristics from TNF inhibitor biosimilar studies in patients with rheumatoid arthritis.
Arthritis research & therapy · 2020.8 · Smolen JS, Kang YM, Yoo WH 외 7
- Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3.
Targeted oncology · 2020.8 · Lüftner D, Lyman GH, Gonçalves J 외 2
- A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.
Lung cancer (Amsterdam, Netherlands) · 2020.8 · Reck M, Luft A, Bondarenko I 외 8
- Intranasal delivery of cancer-targeting doxorubicin-loaded PLGA nanoparticles arrests glioblastoma growth.
Journal of drug targeting · 2020.7 · Chung K, Ullah I, Kim N 외 7
- Targeted Delivery of Recombinant Heat Shock Protein 27 to Cardiomyocytes Promotes Recovery from Myocardial Infarction.
Molecular pharmaceutics · 2020.6 · Kim N, Ullah I, Chung K 외 8
- The Path Towards a Tailored Clinical Biosimilar Development.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020.6 · Schiestl M, Ranganna G, Watson K 외 6
- WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.
Biologicals : journal of the International Association of Biological Standardization · 2020.5 · Wadhwa M, Kang HN, Jivapaisarnpong T 외 55
- Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020.4 · Ebbers HC, Fehrmann B, Ottosen M 외 8
- Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis.
RMD open · 2020.1 · Smolen JS, Choe JY, Weinblatt ME 외 7
- Comparison of the Pharmacokinetics, Safety, and Tolerability of the Autoinjector (AI) and Pre-Filled Syringe (PFS) of SB4 in Healthy Subjects.
Drug design, development and therapy · 2020.1 · Shin D, Kim Y, Go A 외 1
- Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019.12 · Paek K, Kim GW, Ahn SY 외 4
- Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer.
European journal of cancer (Oxford, England : 1990) · 2019.10 · Pivot X, Pegram M, Cortes J 외 7
- The rise of oncology biosimilars: from process to promise.
Future oncology (London, England) · 2019.10 · Verrill M, Declerck P, Loibl S 외 2
- Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis.
Advances in therapy · 2019.9 · Rho YH, Rychlewska-Hańczewska A, Śliwowska B 외 1
- Anti-TNF biosimilars in Crohn's Disease: a patient-centric interdisciplinary approach.
Expert review of gastroenterology & hepatology · 2019.8 · Peyrin-Biroulet L, Danese S, Cummings F 외 4
- Polycyclic aromatic hydrocarbons in seasoned-roasted laver and their reduction according to the mixing ratio of seasoning oil and heat treatment in a model system.
Food science and biotechnology · 2019.8 · Kang SJ, Yang SY, Lee JW 외 1
- Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019.8 · Lee JH, Paek K, Moon JH 외 3
- Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties.
Advances in therapy · 2019.7 · Yun J, Kim J, Chung J 외 2
- ERK/Nrf2 pathway activation by caffeic acid in HepG2 cells alleviates its hepatocellular damage caused by t-butylhydroperoxide-induced oxidative stress.
BMC complementary and alternative medicine · 2019.6 · Yang SY, Pyo MC, Nam MH 외 1
- Protective effects of chebulic acid from Terminalia chebula Retz. against t-BHP-induced oxidative stress by modulations of Nrf2 and its related enzymes in HepG2 cells.
Food science and biotechnology · 2019.4 · Jung HL, Yang SY, Pyo MC 외 4
- Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®.
Biologicals : journal of the International Association of Biological Standardization · 2019.3 · Lee JJ, Yang J, Lee C 외 3
- Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis.
Current medical research and opinion · 2019.3 · Ghil J, Zielińska A, Lee Y
- Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature.
Advances in therapy · 2019.2 · Park D, Yun J, Hwang SJ 외 1
- Nurses are Critical in Aiding Patients Transitioning to Biosimilars in Inflammatory Bowel Disease: Education and Communication Strategies.
Journal of Crohn's & colitis · 2019.2 · Armuzzi A, Avedano L, Greveson K 외 1
- Era of biosimilars in rheumatology: reshaping the healthcare environment.
RMD open · 2019.1 · Smolen JS, Goncalves J, Quinn M 외 2
- Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab.
mAbs · 2019.1 · Lee N, Lee JJ, Yang H 외 6
- SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis.
Therapeutic advances in gastroenterology · 2019.1 · Goncalves J, Myung G, Park M 외 2
- Multi-block Analysis of Genomic Data Using Generalized Canonical Correlation Analysis.
Genomics & informatics · 2018.12 · Jun I, Choi W, Park M
- Protein kinase CK2 activation is required for transforming growth factor β-induced epithelial-mesenchymal transition.
Molecular oncology · 2018.10 · Kim S, Ham S, Yang K 외 1
- The transgenic chicken derived anti-CD20 monoclonal antibodies exhibits greater anti-cancer therapeutic potential with enhanced Fc effector functions.
Biomaterials · 2018.6 · Kim YM, Park JS, Kim SK 외 8
- Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis: Fifty-Two-Week Phase III Randomized Study Results.
Arthritis & rheumatology (Hoboken, N.J.) · 2018.6 · Weinblatt ME, Baranauskaite A, Dokoupilova E 외 7
- Evaluation of the physicochemical and biological stability of reconstituted and diluted SB2 (infliximab).
European journal of hospital pharmacy : science and practice · 2018.5 · Kim J, Chung J, Park S 외 2
- Selective isolation and noninvasive analysis of circulating cancer stem cells through Raman imaging.
Biosensors & bioelectronics · 2018.4 · Cho HY, Hossain MK, Lee JH 외 6
- A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results.
European journal of cancer (Oxford, England : 1990) · 2018.4 · Pivot X, Bondarenko I, Nowecki Z 외 13
- Comparison of injection-site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a phase III study.
The British journal of dermatology · 2018.3 · Girolomoni G, Feldman SR, Emery P 외 4
- Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.
Annals of the rheumatic diseases · 2018.2 · Smolen JS, Choe JY, Prodanovic N 외 12
- Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects.
Drug design, development and therapy · 2018.1 · Shin D, Lee Y, Jeong D 외 1
- Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis.
Arthritis & rheumatology (Hoboken, N.J.) · 2018.1 · Weinblatt ME, Baranauskaite A, Niebrzydowski J 외 8
- 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis.
Rheumatology (Oxford, England) · 2017.12 · Emery P, Vencovský J, Sylwestrzak A 외 10
- A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers.
Journal of clinical pharmacy and therapeutics · 2017.12 · Shin D, Lee Y, Kim H 외 2
- Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4.
Annals of the rheumatic diseases · 2017.11 · Emery P, Vencovský J, Sylwestrzak A 외 7
- Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.
Rheumatology (Oxford, England) · 2017.10 · Smolen JS, Choe JY, Prodanovic N 외 12
- Glycosylation profile and biological activity of Remicade® compared with Flixabi® and Remsima®.
mAbs · 2017.1 · Lee C, Jeong M, Lee JJ 외 4
- Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.
mAbs · 2017.1 · Kim S, Song J, Park S 외 7
- Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab).
mAbs · 2017.1 · Hong J, Lee Y, Lee C 외 13
- A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.
Annals of the rheumatic diseases · 2017.1 · Choe JY, Prodanovic N, Niebrzydowski J 외 12
- A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy.
Annals of the rheumatic diseases · 2017.1 · Emery P, Vencovský J, Sylwestrzak A 외 10
- Difference between SB4 and reference etanercept in the hepatobiliary disorders not considered to be caused by SB4: response to letter by Scheinberg and Azevedo.
Annals of the rheumatic diseases · 2016.10 · Emery P, Vencovský J, Ghil J 외 2
- Overexpression of Endoplasmic Reticulum Oxidoreductin 1-α (ERO1L) Is Associated with Poor Prognosis of Gastric Cancer.
Cancer research and treatment · 2016.10 · Seol SY, Kim C, Lim JY 외 5
- Response to: 'Lower anti-drug antibodies with etanercept biosimilar: Can Ctrough explain the differences' by Shah.
Annals of the rheumatic diseases · 2016.9 · Emery P, Vencovský J, Ghil J 외 1
- Novel strategy for a bispecific antibody: induction of dual target internalization and degradation.
Oncogene · 2016.8 · Lee JM, Lee SH, Hwang JW 외 15
- A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects.
Clinical therapeutics · 2016.7 · Pivot X, Curtit E, Lee YJ 외 6
- Confirmation on the immunogenicity assay used in the SB4 phase III study: response to the comments by Meacci et al.
Annals of the rheumatic diseases · 2016.7 · Emery P, Vencovský J, Kang JW 외 1
- Response to: 'Comparing the immunogenicity of the etanercept biosimilar SB4 with the innovator etanercept: another consideration' by Marshall et al.
Annals of the rheumatic diseases · 2016.7 · Emery P, Vencovský J, Ghil J 외 1
- A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects.
British journal of clinical pharmacology · 2016.7 · Lee YJ, Shin D, Kim Y 외 3
- Response to: 'Reporting of potential immunogenicity with biologic drugs: clarity and accuracy required' by Moots et al.
Annals of the rheumatic diseases · 2016.5 · Emery P, Vencovský J, Ghil J
- Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept.
mAbs · 2016.1 · Cho IH, Lee N, Song D 외 5
- A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade(®)) in Healthy Subjects.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2015.12 · Shin D, Kim Y, Kim YS 외 2
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