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Original Research

Comparative functional and pharmacological characterization of Sandoz proposed biosimilar adalimumab (GP2017): rationale for extrapolation across indications

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Pages 921-930 | Received 14 May 2018, Accepted 27 Jun 2018, Published online: 16 Jul 2018

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Read on this site (5)

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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Anurag Rathore & Himanshu Malani. (2022) Need for a risk-based control strategy for managing glycosylation profile for biosimilar products. Expert Opinion on Biological Therapy 22:2, pages 123-131.
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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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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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Oliver von Richter, Lena Lemke, Halimuniyazi Haliduola, Rainard Fuhr, Thomas Koernicke, Ellen Schuck, Maria Velinova, Andrej Skerjanec, Johann Poetzl & Julia Jauch-Lembach. (2019) GP2017, an adalimumab biosimilar: pharmacokinetic similarity to its reference medicine and pharmacokinetics comparison of different administration methods. Expert Opinion on Biological Therapy 19:10, pages 1075-1083.
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Articles from other publishers (17)

Claudiu Costinel Popescu, Corina Delia Mogoșan, Luminița Enache & Cătălin Codreanu. (2022) Comparison of Efficacy and Safety of Original and Biosimilar Adalimumab in Active Rheumatoid Arthritis in a Real-World National Cohort. Medicina 58:12, pages 1851.
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Lluís Puig, Kave Shams, Fabricio Furlan, Cristofer Salvati, Elisa Romero, Jamie Fan & Lars Iversen. (2022) Real-World Effectiveness and Safety of SDZ-ADL (Adalimumab Biosimilar) in Patients with Psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR). Biologics 2:4, pages 213-225.
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Paola Karp, Matías Gatto, María Victoria Batto, Sol Ferrero & Gustavo Helguera. 2022. Biosimilars. Biosimilars.
Hui Xiong, Fengyan Luo, Pengfei Zhou & Jizu Yi. (2021) Development of a reporter gene method to measure the bioactivity of anti-CD38 × CD3 bispecific antibody. Antibody Therapeutics 4:4, pages 212-221.
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Luisa-Fernanda Rojas-Chavarro & Fernando de Mora. (2021) Extrapolation: Experience gained from original biologics. Drug Discovery Today 26:8, pages 2003-2013.
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Serena Patel & Meenu Wadhwa. (2021) Therapeutic use of specific tumour necrosis factor inhibitors in inflammatory diseases including COVID-19. Biomedicine & Pharmacotherapy 140, pages 111785.
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Meenu Wadhwa, Chris Bird, Eleanor Atkinson, Isabelle Cludts & Peter Rigsby. (2021) The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring. Frontiers in Immunology 12.
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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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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens & Helga Gardarsdottir. (2021) Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars. Pharmaceuticals 14:3, pages 189.
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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens & Helga Gardarsdottir. (2021) Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. Biologicals 69, pages 30-37.
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Ali M. Alsamil, Thijs J. Giezen, Toine C. Egberts, Hubert G. Leufkens, Arnold G. Vulto, Martijn R. van der Plas & Helga Gardarsdottir. (2020) Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review. European Journal of Pharmaceutical Sciences 154, pages 105501.
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Lan Wang, Chuanfei Yu & Junzhi Wang. (2020) Development of reporter gene assays to determine the bioactivity of biopharmaceuticals. Biotechnology Advances 39, pages 107466.
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Ana Valido, Filipe C. Araújo, João Eurico Fonseca & João Gonçalves. (2019) A Review of Adalimumab Biosimilars for the Treatment of Immune-Mediated Rheumatic Conditions. EMJ Rheumatology, pages 122-133.
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Obinna C. Ubah, John Steven, Andrew J. Porter & Caroline J. Barelle. (2019) An Anti-hTNF-α Variable New Antigen Receptor Format Demonstrates Superior in vivo Preclinical Efficacy to Humira® in a Transgenic Mouse Autoimmune Polyarthritis Disease Model. Frontiers in Immunology 10.
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D. J. Buurman, T. Blokzijl, E. A. M. Festen, B. T. Pham, K. N. Faber, E. Brouwer & G. Dijkstra. (2018) Quantitative comparison of the neutralizing capacity, immunogenicity and cross-reactivity of anti-TNF-α biologicals and an Infliximab-biosimilar. PLOS ONE 13:12, pages e0208922.
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Young-A Heo. (2018) GP2017: An Adalimumab Biosimilar. BioDrugs 32:6, pages 635-638.
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