Publications

논문

삼성바이오에피스 제품과 관련된 논문입니다.

Etanercept Biosimilar
  • 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
  • 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 Journal:European Journal of Cancer Authors:Xavier Pivot, Igor Bondarenko, Zbigniew Nowecki, Mikhail Dvorkin, Ekaterina Trishkina, Jin-Hee Ahn, Seock-Ah Im, Tomasz Sarosiek, Sanjoy Chatterjee, Marek Z. Wojtukiewicz, Yaroslav Shparyk, Vladimir Moiseyenko, Maximino Bello III, Vladimir Semiglazov, Younju Lee, Jaeyun Lim Feb 2018
  • Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer Journal:Journal of Clinical Oncology Authors:Xavier Pivot, Igor Bondarenko, Zbigniew Nowecki, Mikhail Dvorkin, Ekaterina Trishkina, Jin-Hee Ahn, Yuriy Vinnyk, Seock-Ah Im, Tomasz Sarosiek, Sanjoy Chatterjee, Marek Z. Wojtukiewicz, Vladimir Moiseyenko, Yaroslav Shparyk, Maximino Bello III, Vladimir Semiglazov, Sujeong Song, and Jaeyun Lim Jan 2018
  • 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 Journal:Annals of the Rheumatic Diseases Authors:Josef S Smolen, Jung-Yoon Choe, Nenad Prodanovic, Jaroslaw Niebrzydowski, Ivan Staykov, Eva Dokoupilova, Asta Baranauskaite, Roman Yatsyshyn, Mevludin Mekic, Wieslawa Porawska, Hana Ciferska, Krystyna Jedrychowicz-Rosiak, Agnieszka Zielinska, Younju Lee, Young Hee Rho Oct 2017
  • Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid Arthritis Journal:Arthritis & Rheumatology Authors:Michael E. Weinblatt, Asta Baranauskaite, Jaroslaw Niebrzydowski, Eva Dokoupilova, Agnieszka Zielinska, Janusz Jaworski, Artur Racewicz, Margarita Pileckyte, Krystyna Jedrychowicz-Rosiak, Soo Yeon Cheong, and Jeehoon Ghil Sep 2017
  • 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis Journal:Oxford Rheumatology Authors:Paul Emery, Jiří Vencovský, Anna Sylwestrzak, Piotr Leszczyński, Wieslawa Porawska, Asta Baranauskaite, Vira Tseluyko, Vyacheslav M. Zhdan, Barbara Stasiuk, Roma Milasiene, Aaron Alejandro Barrera Rodriguez, Soo Yeon Cheong and Jeehoon Ghil Aug 2017
  • Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4 Journal:Annals of the Rheumatic Diseases Authors:Paul Emery, Jiří Vencovský, Anna Sylwestrzak, Piotr Leszczyński, Wieslawa Porawska, Barbara Stasiuk, Joanna Hilt, Zdenka Mosterova, Soo Yeon Cheong, Jeehoon Ghil Aug 2017
  • Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results Journal:Oxford Rheumatology Authors:Josef S. Smolen, Jung-Yoon Choe, Nenad Prodanovic, Jaroslaw Niebrzydowski, Ivan Staykov, Eva Dokoupilova, Asta Baranauskaite, Roman Yatsyshyn, Mevludin Mekic, Wieskawa Porawska, Hana Ciferska, Krystyna Jedrychowicz-Rosiak, Agnieszka Zielinska, Jasmine Choi and Young Hee Rho Jul 2017
  • A randomized phase I comparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers Journal:Journal of Clinical Pharmacy and Therapeutics Authors:Donghoon Shin, Yoon Jung Lee, Hansook Kim, Thomas Körnicke, Rainard Fuhr Jul 2017
  • A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects Journal:Clinical Therapeutics Authors:Xavier Pivot, Elsa Curtit, Yoon Jung Lee, George Golor, Anke Gauliard, Donghoon Shin, Youngdoe Kim, Hansook Kim, RainardFuhr Jun 2016
  • A randomized phase l pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects Journal:British Journal of Clinical Pharmacology Authors:Yoon Jung Lee, Donghoon Shin, Youngdoe Kim, Jungwon Kang, Anke Gauliard, Rainard Fuhr Mar 2016
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