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

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)

Stanley B. CohenDepartment of Internal Medicine, Metroplex Clinical Research Center, Dallas, TX, USACorrespondence[email protected] [email protected]
View further author information
,
Niklas CzelothBioscience, Boehringer Ingelheim, Ingelheim, GermanyView further author information
,
Eric LeeInland Rheumatology, Upland, CA, USAView further author information
,
Piotr A. KlimiukDepartment of Rheumatology and Internal Diseases, Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, PolandView further author information
,
Nuala PeterMedical, Boehringer Ingelheim, Biberach, GermanyView further author information
&
Girish JayadevaBioscience, Boehringer Ingelheim, Ingelheim, GermanyView further author information
Pages 1097-1105 | Received 26 Jun 2019, Accepted 15 Jul 2019, Published online: 06 Aug 2019

References

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  • Generics and Biosimilars Initiative (GABI). Biosimilars of adalimumab; [ Updated 29 June 2018]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
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  • Bridges SL Jr., White DW, Worthing AB, et al. The science behind biosimilars: entering a new era of biologic therapy. Arthritis Rheumatol. 2018;70(3):334–344.
  • Singh JA, Hossain A, Tanjong Ghogomu E, et al. Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2017;3:CD012591.
  • Wynne C, Altendorfer M, Sonderegger I, et al. 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(R)-PK) in healthy subjects. Expert Opin Investig Drugs. 2016;25(12):1361–1370.
  • Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Ann Rheum Dis. 2018;77(6):914–921.
  • Generics and Biosimilars Initiative (GABI). Biosimilars approved in Europe; [ Updated 14 Dec 2018]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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  • Smolen JS, Goncalves J, Quinn M, et al. Era of biosimilars in rheumatology: reshaping the healthcare environment. RMD Open. 2019;5(1):e000900.

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