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Yeo-Jin Song, Seoung Wan Nam, Chang Hee Suh, Jung Yoon Choe & Dae Hyun Yoo. (2023) Biosimilars in the treatment of rheumatoid arthritis: a pharmacokinetic overview. Expert Opinion on Drug Metabolism & Toxicology 19:11, pages 751-768.
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Oliver von Richter, Terry O’Reilly, Davide Guerrieri, Jamie Fan, Constanze Fey, Steven Schussler, Fabricio Furlan & Lena Lemke. (2023) GP2017-HCF, a high concentration formulation, demonstrates similar pharmacokinetics, immunogenicity and safety to GP2017, an approved adalimumab biosimilar. Expert Opinion on Biological Therapy 23:8, pages 749-758.
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Ronak Patel, Pravin Ghadge, Pravin A. Nair, Manish Kumar & Laxmi Adhikary. (2022) A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA). Expert Opinion on Biological Therapy 22:10, pages 1293-1310.
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Christopher Wynne, Christian Schwabe, Charlotte Lemech, Heimo Stroissnig, Roshan Dias, Joanna Sobierska, Eric Guenzi, Hendrik Otto, Abid Sattar, Richard Kay, Halimu N. Haliduola & Fausto Berti. (2022) A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST). Expert Opinion on Investigational Drugs 31:9, pages 965-976.
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Guangwen Liu, Zhongnan Xu, Wei Yang, Jinling Xue, Yanli Wang, Zhengzhi Liu, Yingzi Cui, Xinyao Qu, Tianying Chang, Shuang Yu, Yang Cheng, Yannan Zhou, Jiahui Chen, Qing Ren, Wanhua Wang, Qiaohuan Deng, Zeyu Wang & Haimiao Yang. (2022) A randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects. Expert Opinion on Biological Therapy 22:2, pages 187-195.
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Xin Zhou, Zhuo Chen & Xinling Bi. (2021) An Update Review of Biosimilars of Adalimumab in Psoriasis – Bioequivalence and Interchangeability. Drug Design, Development and Therapy 15, pages 2987-2998.
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Oliver von Richter, Lena Lemke, Halimuniyazi Haliduola, Alison Balfour, Britta Zehnpfennig, Andrej Skerjanec & Julia Jauch-Lembach. (2019) Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar. Expert Opinion on Biological Therapy 19:10, pages 1057-1064.
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Articles from other publishers (18)
Davide Guerrieri, Matej Horvat, Jamie Fan, Jessie Wang, Lena Lemke, Oliver von Richter & Johann Poetzl. (2023) Signal-to-noise ratio to assess magnitude, kinetics and impact on pharmacokinetics of the immune response to an adalimumab biosimilar. Bioanalysis.
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Steven R. Feldman, Richard Kay, Nataliya Reznichenko, Joanna Sobierska, Roshan Dias, Hendrik Otto, Halimu N. Haliduola, Abid Sattar, Ruth Ruffieux, Heimo Stroissnig & Fausto Berti. (2023) Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study. BioDrugs.
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Miwa Haranaka, Takanori Tanaka, SungHyun Kim, YunJu Bae, DaBee Jeon, EunJin Choi, JungBin Cha, SangMi Lee & Yoichiro Ogama. (2023) Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults. Immunotherapy 15:3, pages 149-161.
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Halimu N. Haliduola, Fausto Berti, Heimo Stroissnig, Eric Guenzi, Hendrik Otto, Abid Sattar & Ulrich Mansmann. (2022) Joint analysis of PK and immunogenicity outcomes using factorization model − a powerful approach for PK similarity study. BMC Medical Research Methodology 22:1.
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Juan Carlos Rondon, Oliver Von Richter, Constanze Fey, Jamie Fan, Fabricio Furlan & Lena Lemke. (2022) S1057 A Randomized Phase I Study Comparing Pharmacokinetics, Safety and Immunogenicity of High Concentration Formulation (100 mg/mL) With GP2017 Formulation (50 mg/mL), an Adalimumab Biosimilar, in Healthy Male Subjects. American Journal of Gastroenterology 117:10S, pages e765-e766.
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Yingying Song, Hui Cui, Tiangang Zhang, Tingxiao Yang, Xiaokun Li & Ping Xuan. (2022) Prediction of Drug-Related Diseases Through Integrating Pairwise Attributes and Neighbor Topological Structures. IEEE/ACM Transactions on Computational Biology and Bioinformatics 19:5, pages 2963-2974.
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Alyson Yamaguchi, Jacques Van Dam, Arvinder K. Dhalla, Kyle Horlen, Mir Imran, April T. Vo & Mir A. Hashim. (2022) Transenteric delivery of antibodies via an orally ingestible robotic pill yields high bioavailability comparable to parenteral administration in awake canines. Frontiers in Drug Delivery 2.
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Paola Karp, Matías Gatto, María Victoria Batto, Sol Ferrero & Gustavo Helguera. 2022. Biosimilars. Biosimilars.
Long Liu, Lu Qi, Chunpu Lei, Yu Wang, Wei Zhang, Ying Liu, Pu Li, Haihong Bai, Yan Li, Yinjuan Li, Ju Liu, Liangzhi Xie & Xinghe Wang. (2022) Phase I, randomized, double-blind, single-dose study to assess the pharmacokinetics, safety, and immunogenicity of the proposed biosimilar SCT630 and adalimumab in healthy Chinese subjects. International Immunopharmacology 106, pages 108599.
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Fuyu Song, Xin Zheng, Yujia Wang, Shein-Chung Chow & Hongqiang Sun. (2021) Innovative Design and Analysis for PK/PD Biosimilar Bridging Studies with Multiple References. The AAPS Journal 24:1.
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Antonia Davidson, Darin Brimhall, Jonathan Kay, Edward Keystone, Sang Joon Lee, Sung Hyun Kim, Yun Ju Bae, Eun Jin Choi & Daniel E. Furst. (2021) Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects. British Journal of Clinical Pharmacology 87:11, pages 4323-4333.
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Donna S. Cox, Daniel F. Alvarez, Amy E. Bock & Carol L. Cronenberger. (2021) Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects. Clinical Pharmacology in Drug Development 10:10, pages 1166-1173.
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Kyung‐Sang Yu, In‐Jin Jang, Hyeong‐Seok Lim, Jang Hee Hong, Min‐Gul Kim, Min Kyu Park, Doo‐Yeoun Cho, Min Soo Park, Jae Yong Chung, Jong‐Lyul Ghim, SeungHwan Lee, Seok Kyu Yoon, In Sun Kwon, Sang Joon Lee, Sung Hyun Kim, Yun Ju Bae, Jung Bin Cha, Daniel E. Furst, Edward Keystone & Jonathan Kay. (2021) Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clinical and Translational Science 14:4, pages 1280-1291.
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XiaoQin Lu, Rui Hu, Lin Peng, MengSi Liu & Zhen Sun. (2021) Efficacy and Safety of Adalimumab Biosimilars: Current Critical Clinical Data in Rheumatoid Arthritis. Frontiers in Immunology 12.
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Tom W. J. Huizinga, Yoshifumi Torii & Rafael Muniz. (2020) Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatology and Therapy 8:1, pages 41-61.
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Chang Liu, Wenliang Dong, Lin Xia, Jie Lv, Daoli Jiang, Qian Wang, Mei Wang, Maofeng Wu, Jingwei Miao, Tao Tao, Dong Wang, Lili Zheng, Shiguang Su, Lizhong Liu & Yi Fang. (2021) Safety and tolerability of a humanized rabbit monoclonal antibody (SSS07) in healthy adults: Randomized double-blind placebo-controlled single ascending dose trial. International Immunopharmacology 91, pages 107263.
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Chien-Lung Tu, Yi-Lin Wang, Teh-Min Hu & Li-Feng Hsu. (2019) Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development?. BioDrugs 33:4, pages 437-446.
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