Publications
논문
삼성바이오에피스 제품과 관련된 논문입니다.
Etanercept Biosimilar
- Comparison of SB17 and reference ustekinumab in healthy adults: A randomized, double-blind, single-dose, phase I study Journal:Int J Clin Pharmacol Ther Authors:Hansol Jeong, Taeseung Kang, Jiyoon Lee, Seongsik Im May 2024
- 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:J Am Acad Dermato Authors:Steven R Feldman, Joanna Narbutt, Giampiero Girolomoni, Jan Brzezicki, Nataliya Reznichenko, Maria Agnieszka Zegadło-Mylik, Grazyna Pulka, Magdalena Dmowska-Stecewicz, Elżbieta Kłujszo, Dmytro Rekalov, Lidia Rajzer, Jiyoon Lee, Minkyung Lee, Young Hee Rho Apr 2024
- Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial Journal:BMJ Open Ophthalmology Authors:SriniVas R Sadda, Mario Bradvica, Attila Vajas, Min Sagong, Jan Ernest, Jan Studnička, Miroslav Veith, Edward Wylegala, Sunil Patel, Cheolmin Yun, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár , Adrienne Csutak, Lajos Enyedi, Wooree Choi, Inkyung Oh, Hyerin Jang, Se Joon Woo Dec 2023
- 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 Journal:Expert Opinion on Investigational Drugs Authors:Hyun A Lee, Sujung Kim, Hyoryeong Seo, Soyeon Kim Nov 2023
- Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial. Journal:JAMA Ophthalmology Authors:Se Joon Woo, Mario Bradvica, Attila Vajas, Min Sagong, Jan Ernest, Jan Studnicka, Miroslav Veith, Edward Wylegala, Sunil Patel, Cheolmin Yun, Michal Orski, Sergei Astakhov, Edit Tóth-Molnár, Adrienne Csutak, Lajos Enyedi, Taehyung Kim, Inkyung Oh, Hyerin Jang, SriniVas R Sadda Jul 2023
- A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. Journal:eJHaem Authors:Jun Ho Jang , Roberta Demichelis Gomez, Horia Bumbea, Larysa Nogaieva, Lily Lee Lee Wong, Soo Min Lim, Younsoo Kim, Jihye Park Dec 2022
- A randomized, double-blind, three-arm, parallel group, single-dose phase I study to evaluate the pharmacokinetic similarity between SB12 (a proposed eculizumab biosimilar) and eculizumab (Soliris) in healthy subjects. Journal:Int J Clin Pharmacol Ther Authors:Hyun A Lee, Hyerin Jang, Deokyoon Jeong, Younsoo Kim, Rainard Fuhr Jun 2022
- 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) Journal:Rheumatology and Therapy Authors:So-shin Ahn, Minkyung Lee, Yumin Baek, Sukho Lee Jul 2022
- Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes Journal:British Journal of Ophthalmology Authors:Neil M Bressler, Miroslav Veith, Jan Hamouz, Jan Ernest, Dominik Zalewski, Jan Studnička, Attila Vajas, András Papp, Gabor Vogt, James Luu, Veronika Matuskova, Young Hee Yoon, Tamás Pregun, Taehyung Kim, Donghoon Shin, Inkyung Oh, Hansol Jeong, Mercy Yeeun Kim, Se Joon Woo 0ct 2021
- 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 Journal:JAMA Ophthalmology Authors:Se Joon Woo, Miroslav Veith, Jan Hamouz, Jan Ernest, Dominik Zalewski, Jan Studnicka, Attila Vajas, Andras Papp, Vogt Gabor, James Luu, Veronika Matuskova, Young Hee Yoon, Tamás Pregun, Taehyung Kim, Donghoon Shin, Neil M Bressler Nov 2020
- 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 Journal:Lung Cancer Authors:Martin Reck, Alexander Luft, Igor Bondarenko, Serhii Shevnia, Dmytro Trukhin, Nadezhda V. Kovalenko, Kakha Vacharadze, Fülöp Andrea, Anatoliy Hontsa, Jihye Choi, Donghoon Shin May 2020
- 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 Journal:European Journal of Cancer Authors:Xavier Pivot, Mark Pegram, Javier Cortes, Diana Luftner, Gary H. Lyman, Giuseppe Curigliano, Igor Bondarenko, Ye Chan Yoon, Younsoo Kim, Chul Kim Aug 2019
- Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis Journal:Current Medical Research and Opinion Authors:Jeehoon Ghil, Agnieszka Zielińska, Younju Lee Jan 2019
- Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects Journal:Drug Design, Development and Therapy Authors:Donghoon Shin, Younju Lee, Deokyoon Jeong, Rod Ellis-Pegler Nov 2018
- Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid Arthritis Journal:Arthritis & Rheumatology Authors:Michael E. Weinblatt, Asta Baranauskaite, Eva Dokoupilova, Agnieszka Zielinska, Janusz Jaworski, Artur Racewicz, Margarita Pileckyte, Krystyna Jedrychowicz-Rosiak, Inyoung Baek, and Jeehoon Ghil Jun 2018
