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Expert Opinion on Investigational Drugs Volume 25, 2016 - Issue 12
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Original Research

Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

Christopher WynneChristchurch Clinical Studies Trust, Christchurch, New ZealandView further author information
,
Mario AltendorferBoehringer Ingelheim, Ingelheim, GermanyView further author information
,
Ivo SondereggerBoehringer Ingelheim, Ingelheim, GermanyView further author information
,
Lien GheyleSGS, Clinical Pharmacology Unit, Antwerp, BelgiumView further author information
,
Rod Ellis-PeglerAuckland Clinical Studies Limited, Auckland, New ZealandView further author information
,
Susanne BuschkeBoehringer Ingelheim, Ingelheim, GermanyView further author information
,
Benjamin LangBoehringer Ingelheim, Ingelheim, GermanyView further author information
,
Deepak AssudaniBoehringer Ingelheim, Ingelheim, GermanyCorrespondence[email protected]
View further author information
,
Sandeep AthalyeBoehringer Ingelheim, Ingelheim, GermanyView further author information
&
Niklas CzelothBoehringer Ingelheim, Ingelheim, GermanyView further author information
 show all
Pages 1361-1370 | Received 31 Aug 2016, Accepted 28 Oct 2016, Published online: 18 Nov 2016

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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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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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Yanli Wang, Zhenyue Gao, Zhengzhi Liu, Guangwen Liu, Xinyao Qu, Jiahui Chen, Xinran Ren, Zhongnan Xu & Haimiao Yang. (2022) A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers. Expert Opinion on Biological Therapy 22:2, pages 225-234.
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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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Alan Menter, Petr Arenberger, Sigrid Balser, Stefan Beissert, Ashley Cauthen, Niklas Czeloth, Jennifer Soung, Sasha Jazayeri, Peter Weisenseel & Girish Jayadeva. (2021) Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study. Expert Opinion on Biological Therapy 21:1, pages 87-96.
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Fabrizio Cantini, Maurizio Benucci, Francesca Li Gobbi, Giulia Franchi & Laura Niccoli. (2019) Biosimilars for the treatment of psoriatic arthritis. Expert Review of Clinical Immunology 15:11, pages 1195-1203.
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Stanley B. Cohen, Niklas Czeloth, Eric Lee, Piotr A. Klimiuk, Nuala Peter & Girish Jayadeva. (2019) Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext). Expert Opinion on Biological Therapy 19:10, pages 1097-1105.
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Gionata Fiorino, Daniela Gilardi, Carmen Correale, Federica Furfaro, Giulia Roda, Laura Loy, Marjorie Argollo, Mariangela Allocca, Laurent Peyrin-Biroulet & Silvio Danese. (2019) Biosimilars of adalimumab: the upcoming challenge in IBD. Expert Opinion on Biological Therapy 19:10, pages 1023-1030.
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Mercedes Gimeno-Gracia, Carla J. Gargallo-Puyuelo & Fernando Gomollón. (2019) Bioequivalence studies with anti-TNF biosimilars. Expert Opinion on Biological Therapy 19:10, pages 1031-1043.
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Stanley Cohen, Piotr A. Klimiuk, Tillmann Krahnke & Deepak Assudani. (2018) Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE®-RL). Expert Opinion on Drug Delivery 15:6, pages 545-548.
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