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Expert Opinion on Biological Therapy Volume 19, 2019 - Issue 10: Biosimilars
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Original Research

Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar

Oliver von RichterGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyView further author information
,
Lena LemkeGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyView further author information
,
Halimuniyazi HaliduolaGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyView further author information
,
Alison BalfourGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyView further author information
,
Britta ZehnpfennigGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyView further author information
,
Andrej SkerjanecClinical Pharmacology Biosimilars, Sandoz AG, Novartis Company, Basel, SwitzerlandView further author information
&
Julia Jauch-LembachGlobal Clinical Development, Biopharmaceuticals, Hexal AG (A Sandoz Company), Holzkirchen, GermanyCorrespondence[email protected]
View further author information
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Pages 1057-1064 | Received 22 Feb 2019, Accepted 01 Apr 2019, Published online: 19 Apr 2019

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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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Articles from other publishers (4)

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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Hong Zhang, Hong Chen, Xiaojiao Li, Min Wu, Xiaoxue Zhu, Cuiyun Li, Jingrui Liu, Haijing Wei, Yue Hu, Jingjing Wang, Yongmin Yang, Xiangyang Zhu & Yanhua Ding. (2021) A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects. Frontiers in Pharmacology 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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Martin Schiestl, Gopinath Ranganna, Keith Watson, Byoungin Jung, Karsten Roth, Björn Capsius, Michael Trieb, Peter Bias & Julie Maréchal-Jamil. (2020) The Path Towards a Tailored Clinical Biosimilar Development. BioDrugs 34:3, pages 297-306.
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