Below are the most recent publications written about "Biosimilar Pharmaceuticals" by people in Profiles.
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Kay J, Cross RK, Feldman SR, Park Y, Hanauer SB. Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases. Adv Ther. 2024 02; 41(2):509-533.
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Kay J. Multiple switching studies and interchangeability of biosimilars. Lancet Rheumatol. 2023 Sep; 5(9):e499-e501.
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Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 09; 8(2).
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Menter A, Cohen S, Kay J, Strand V, Gottlieb A, Hanauer S, Eduru SK, Buschke S, Lang B, Liesenfeld KH, Schaible J, McCabe D. Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial. Am J Clin Dermatol. 2022 Sep; 23(5):719-728.
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Furst DE, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Kim SH, Bae YJ, Yang GE, Yoo JK, Kay J, Keystone E. Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis. Rheumatology (Oxford). 2022 04 11; 61(4):1385-1395.
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Davidson A, Brimhall D, Kay J, Keystone E, Lee SJ, Kim SH, Bae YJ, Choi EJ, Furst DE. Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40?mg/0.4?mL) by autoinjector and prefilled syringe in healthy subjects. Br J Clin Pharmacol. 2021 11; 87(11):4323-4333.
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Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100?mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 07; 14(4):1280-1291.
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Kay J, Jaworski J, Wojciechowski R, Wiland P, Dudek A, Krogulec M, Jeka S, Zielinska A, Trefler J, Bartnicka-Maslowska K, Krajewska-Wlodarczyk M, Klimiuk PA, Lee SJ, Bae YJ, Yang GE, Yoo JK, Furst DE, Keystone E. Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study. Arthritis Res Ther. 2021 02 05; 23(1):51.
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Alvarez DF, Wolbink G, Cronenberger C, Orazem J, Kay J. Interchangeability of Biosimilars: What Level of Clinical Evidence is Needed to Support the Interchangeability Designation in the United States? BioDrugs. 2020 Dec; 34(6):723-732.
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Baker JF, Leonard CE, Lo Re V, Weisman MH, George MD, Kay J. Biosimilar Uptake in Academic and Veterans Health Administration Settings: Influence of Institutional Incentives. Arthritis Rheumatol. 2020 07; 72(7):1067-1071.