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Regulatory approvals
data.go.kr · openFDA20 Korean MFDS drug approvals · 2015–2026 / 10 US FDA drug approvals · 2017–2025
- MFDS drugSubsidiary: 삼성바이오에피스(주)Epyztek Pre-filled pen2026-01-13Drug · Prescription · Approval202600119
- MFDS drugSubsidiary: 삼성바이오에피스(주)Xbryk 120 mg solution for injection2025-05-30Drug · Prescription · Approval202501346
- MFDS drugSubsidiary: 삼성바이오에피스(주)Obodence 60 mg solution for injection in pre-filled syringe2025-04-04Drug · Prescription · Approval202500817
- MFDS drugSubsidiary: 삼성바이오에피스(주)Afilivu Pre-filled Syringe (Aflibercept)2025-03-13Drug · Prescription · Approval202500560
- FDA drugSubsidiary: 삼성바이오에피스(주)DENOSUMAB-DSSB2025-02-13FDA drug approval · BLABLA761392
- MFDS drugSubsidiary: 삼성바이오에피스(주)AMELIVU PFS2024-11-04Drug · Prescription · Approval202402591
- FDA drugSubsidiary: 삼성바이오에피스(주)EPYSQLI2024-07-19FDA drug approval · BLABLA761340
- FDA drugSubsidiary: 삼성바이오에피스(주)PYZCHIVA2024-06-28FDA drug approval · BLABLA761373
- FDA drugSubsidiary: 삼성바이오에피스(주)PYZCHIVA2024-06-28FDA drug approval · BLABLA761425
- FDA drugSubsidiary: 삼성바이오에피스(주)OPUVIZ2024-05-20FDA drug approval · BLABLA761350
- MFDS drugSubsidiary: 삼성바이오에피스(주)Epyztek IV injection2024-04-11Drug · Prescription · Approval202400826
- MFDS drugSubsidiary: 삼성바이오에피스(주)Epyztek Pre-filled syringe2024-04-11Drug · Prescription · Approval202400827
Show 18 more
- MFDS drugSubsidiary: 삼성바이오에피스(주)Afilivu Injection (Aflibercept)2024-02-23Drug · Prescription · Approval202400392
- MFDS drugSubsidiary: 삼성바이오에피스(주)Epysqli2024-01-19Drug · Prescription · Approval202400147
- MFDS drugSubsidiary: 삼성바이오에피스(주)Adalloce 40 mg/0.4 mL solution for injection in pre-filled pen2023-01-03Drug · Prescription · Approval202300028
- MFDS drugSubsidiary: 삼성바이오에피스(주)Adalloce 40 mg/0.4 mL solution for injection in pre-filled syringe2023-01-03Drug · Prescription · Approval202300029
- MFDS drugSubsidiary: 삼성바이오에피스(주)AMELIVU2022-05-13Drug · Prescription · Approval202202008
- FDA drugSubsidiary: 삼성바이오에피스(주)BYOOVIZ2021-09-17FDA drug approval · BLABLA761202
- MFDS drugSubsidiary: 삼성바이오에피스(주)Onbevzi concentrate for solution for infusion2021-03-11Drug · Prescription · Approval202102237
- MFDS drugSubsidiary: 삼성바이오에피스(주)Samfenet 440 mg powder for concentrate for solution for infusion2020-10-14Drug · Prescription · Approval202007039
- MFDS drugSubsidiary: 삼성바이오에피스(주)Adalloce 40 mg solution for injection in pre-filled penRevoked2020-07-03Drug · Prescription · Approval202004865
- MFDS drugSubsidiary: 삼성바이오에피스(주)Etoloce 50 mg solution for injection in pre-filled pen2019-08-19Drug · Prescription · Approval201905857
- FDA drugSubsidiary: 삼성바이오에피스(주)HADLIMA2019-07-23FDA drug approval · BLABLA761059
- FDA drugSubsidiary: 삼성바이오에피스(주)ETICOVO2019-04-25FDA drug approval · BLABLA761066
- FDA drugSubsidiary: 삼성바이오에피스(주)ONTRUZANT2019-01-18FDA drug approval · BLABLA761100
- MFDS drugSubsidiary: 삼성바이오에피스(주)Samfenet 150 mg powder for concentrate for solution for infusion2017-11-08Drug · Prescription · Approval201707851
- MFDS drugSubsidiary: 삼성바이오에피스(주)Adalloce 40 mg solution for injection in pre-filled syringeRevoked2017-09-20Drug · Prescription · Approval201707153
- FDA drugSubsidiary: 삼성바이오에피스(주)RENFLEXIS2017-04-21FDA drug approval · BLABLA761054
- MFDS drugSubsidiary: 삼성바이오에피스(주)Remaloce 100 mg powder for concentrate for solution for infusion2015-12-04Drug · Prescription · Approval201508122
- MFDS drugSubsidiary: 삼성바이오에피스(주)Etoloce 50 mg solution for injection in pre-filled syringe2015-09-07Drug · Prescription · Approval201506388
Publications
PubMed · affiliation-matched- Why Product Drift Is Not an Issue for Biosimilars/Biologics: Start the Same, Stay the Same.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026-09 · 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 · 2026-04 · 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 · 2025-09 · 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 · 2025-07 · 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 · 2025-06 · 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 · 2025-05 · 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 · 2025-04 · 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 · 2025-04 · 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 · 2025-03 · 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 · 2025-03 · Yang SY, Lee C, Hwang K 외 4
Show 107 more publications
- SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial.
Bone · 2025-03 · Chung YS, Langdahl B, Plebanski R 외 14
- Population pharmacokinetics/pharmacodynamics analysis confirming biosimilarity of SB16 to reference denosumab.
Frontiers in pharmacology · 2025-01 · 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 · 2024-09 · 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 · 2024-09 · Feldman SR, Narbutt J, Girolomoni G 외 11
- Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases.
Advances in therapy · 2024-08 · 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 · 2024-08 · 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 · 2024-02 · Chan H, Trout CV, Mikolon D 외 10
- Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases.
Advances in therapy · 2024-02 · Kay J, Cross RK, Feldman SR 외 2
- Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review.
Survey of ophthalmology · 2024-01 · 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.) · 2024-01 · Woo SJ, Jung JA, Kim T 외 3
- Safety and Effectiveness of Trastuzumab Biosimilar SB3 in Korean Patients, a Post-Marketing Surveillance Study.
Oncology · 2024-01 · 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 · 2023-08 · 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 · 2023-07 · 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 · 2023-07 · 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 · 2023-04 · 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 · 2023-04 · 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 · 2023-04 · Yoo WH, Kang YM, Kim DW 외 8
- Consistency of Product Quality for SB5, an Adalimumab Biosimilar.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023-03 · 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 · 2023-03 · 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 · 2023-03 · 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 · 2023-02 · 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 · 2023-02 · 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 · 2023-02 · 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) · 2023-02 · 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 · 2023-01 · 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 · 2023-01 · 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 · 2023-01 · 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 · 2023-01 · 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 · 2022-08 · 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 · 2022-07 · 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 · 2022-04 · 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 · 2021-06 · 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 · 2021-01 · 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 · 2021-01 · 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 · 2020-09 · 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 · 2020-08 · 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 · 2020-08 · 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) · 2020-08 · Reck M, Luft A, Bondarenko I 외 8
- Intranasal delivery of cancer-targeting doxorubicin-loaded PLGA nanoparticles arrests glioblastoma growth.
Journal of drug targeting · 2020-07 · 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 · 2020-06 · Kim N, Ullah I, Chung K 외 8
- The Path Towards a Tailored Clinical Biosimilar Development.
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020-06 · 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 · 2020-05 · 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 · 2020-04 · 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 · 2020-01 · 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 · 2020-01 · 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 · 2019-09 · 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 · 2019-08 · 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 · 2019-08 · 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 · 2019-08 · 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 · 2019-07 · 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 · 2019-06 · 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 · 2019-04 · 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 · 2019-03 · 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 · 2019-03 · 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 · 2019-02 · 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 · 2019-02 · Armuzzi A, Avedano L, Greveson K 외 1
- Era of biosimilars in rheumatology: reshaping the healthcare environment.
RMD open · 2019-01 · Smolen JS, Goncalves J, Quinn M 외 2
- Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab.
mAbs · 2019-01 · 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 · 2019-01 · 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 · 2018-06 · 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.) · 2018-06 · 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 · 2018-05 · Kim J, Chung J, Park S 외 2
- Selective isolation and noninvasive analysis of circulating cancer stem cells through Raman imaging.
Biosensors & bioelectronics · 2018-04 · 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) · 2018-04 · 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 · 2018-03 · 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 · 2018-02 · 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 · 2018-01 · 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.) · 2018-01 · 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 · 2017-01 · Lee C, Jeong M, Lee JJ 외 4
- Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.
mAbs · 2017-01 · Kim S, Song J, Park S 외 7
- Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab).
mAbs · 2017-01 · 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 · 2017-01 · 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 · 2017-01 · 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 · 2016-09 · Emery P, Vencovský J, Ghil J 외 1
- Novel strategy for a bispecific antibody: induction of dual target internalization and degradation.
Oncogene · 2016-08 · 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 · 2016-07 · 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 · 2016-07 · 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 · 2016-07 · 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 · 2016-07 · 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 · 2016-05 · Emery P, Vencovský J, Ghil J
- Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept.
mAbs · 2016-01 · 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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Founded in 1941 and listed on the KOSPI in 1975, Ildong Holdings is the holding company of the Ildong Pharmaceutical Group, overseeing pharmaceutical, aesthetic medical device, and drug development affiliates.
Founded in 1941 and listed on the KOSPI in 1975, Yuyu Pharma is a pharmaceutical company with a co-promotion agreement with Dong-A ST for Tanamin.
Founded and listed on the KOSPI in 2016, Il Dong Pharmaceutical manufactures products including the Aronamin vitamin line.
Founded 2000, KOSDAQ-listed 2009, Medy-Tox develops and exports botulinum toxin biopharmaceuticals including Meditoxin and Innotox.
KOSPI-listed comprehensive pharmaceutical company specializing in blood products and vaccines, with FDA-approved immunoglobulin ALYGLO.
KOSPI-listed pharmaceutical company behind Coldwon cold medicine and Jangdaewon probiotics, developing a P-CAB drug pipeline.
Founded 2011, listed 2016 — Samsung Biologics is a biopharma CDMO with 785,000L capacity across five Songdo plants.
Founded in 2006 and listed on KOSDAQ in 2020, Genolution is a molecular diagnostics and RNAi company producing nucleic acid extraction reagents and devices.
Founded 2005, KOSDAQ-listed 2022, BIO-FD&C develops plant-cell platform-based cosmeceutical materials and biopharma pipelines.
KOSPI-listed comprehensive pharma company behind Amaryl diabetes drug and the USD 86.25M HL5101 anticancer out-license deal.
Founded in 2007, SK Innovation is an energy company spanning oil, chemicals, batteries, and LNG, merged with SK E&S in 2024.
Cell Biotech ranks No.2 in Denmark's probiotics market and No.1 in Korean probiotics exports, selling its DUOLAC brand.
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