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 TherapyAuthors:So-shin Ahn, Minkyung Lee, Yumin Baek, Sukho LeeJul 2022
Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomesJournal:British Journal of OphthalmologyAuthors: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 Woo0ct 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 TrialJournal:JAMA OphthalmologyAuthors: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 BresslerNov 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 cancerJournal:Lung CancerAuthors:Martin Reck, Alexander Luft, Igor Bondarenko, Serhii Shevnia, Dmytro Trukhin, Nadezhda V. Kovalenko, Kakha Vacharadze, Fülöp Andrea, Anatoliy Hontsa, Jihye Choi, Donghoon ShinMay 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 cancerJournal:European Journal of CancerAuthors:Xavier Pivot, Mark Pegram, Javier Cortes, Diana Luftner, Gary H. Lyman, Giuseppe Curigliano, Igor Bondarenko, Ye Chan Yoon, Younsoo Kim, Chul KimAug 2019
Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritisJournal:Current Medical Research and OpinionAuthors:Jeehoon Ghil, Agnieszka Zielińska, Younju LeeJan 2019
Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjectsJournal:Drug Design, Development and TherapyAuthors:Donghoon Shin, Younju Lee, Deokyoon Jeong, Rod Ellis-PeglerNov 2018
Switching From Reference Adalimumab to SB5 (Adalimumab Biosimilar) in Patients With Rheumatoid ArthritisJournal:Arthritis & RheumatologyAuthors:Michael E. Weinblatt, Asta Baranauskaite, Eva Dokoupilova, Agnieszka Zielinska, Janusz Jaworski, Artur Racewicz, Margarita Pileckyte, Krystyna Jedrychowicz-Rosiak, Inyoung Baek, and Jeehoon GhilJun 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 resultsJournal:European Journal of CancerAuthors: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 LimFeb 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 CancerJournal:Journal of Clinical OncologyAuthors: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 LimJan 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 studyJournal:Annals of the Rheumatic DiseasesAuthors: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 RhoOct 2017
Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate-to-Severe Rheumatoid ArthritisJournal:Arthritis & RheumatologyAuthors: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 GhilSep 2017
52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritisJournal:Oxford RheumatologyAuthors: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 GhilAug 2017
Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4Journal:Annals of the Rheumatic DiseasesAuthors:Paul Emery, Jiří Vencovský, Anna Sylwestrzak, Piotr Leszczyński, Wieslawa Porawska, Barbara Stasiuk, Joanna Hilt, Zdenka Mosterova, Soo Yeon Cheong, Jeehoon GhilAug 2017
Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety resultsJournal:Oxford RheumatologyAuthors: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 RhoJul 2017