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Original Research

Evidence of bioequivalence and positive patient user handling of a tocilizumab autoinjector

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Pages 551-561 | Received 15 Nov 2018, Accepted 04 Apr 2019, Published online: 02 May 2019

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Monika Tomaszewska-Kiecana, Anna Dryja, Martin Ullmann, Corinne Petit-Frere, Andras Illes, Christos Dagres & Joëlle Monnet. (2023) Pharmacokinetics and tolerability of prefilled syringe and auto-injector presentations of MSB11456: results of a randomized, single-dose study in healthy adults. Expert Review of Clinical Immunology 19:4, pages 447-455.
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Monika Tomaszewska-Kiecana, Martin Ullmann, Corinne Petit-Frere, Joëlle Monnet, Christos Dagres & Andras Illes. (2023) Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults. Expert Review of Clinical Immunology 19:4, pages 439-446.
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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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Hong Zhang, Xiaojiao Li, Jingrui Liu, Cuiyun Li, Min Wu, Xiaoxue Zhu, Jixuan Sun, Min Fang & Yanhua Ding. (2021) A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects. Annals of Medicine 53:1, pages 375-383.
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Beate Bittner. (2023) Customer-centric product presentations for monoclonal antibodies. AAPS Open 9:1.
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Roy M. Fleischmann, Amy E. Bock, Wuyan Zhang, Charles M. Godfrey, Ivana Vranic, Carol Cronenberger & Eva Dokoupilová. (2022) Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatology and Therapy 9:3, pages 839-850.
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Hong Zhang, Hong Wang, Haijing Wei, Hong Chen, Jingrui Liu, Cuiyun Li, Xiaoxue Zhu, Xiaojiao Li, Jinchen Yu, Yinbo Zhou, Xiaolei Yang, Zhaohe Wang, Min Wu & Yanhua Ding. (2021) A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Frontiers in Pharmacology 11.
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