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Articles

Successful administration of BI 695501, an adalimumab biosimilar, using an autoinjector (AI): results from a Phase II open-label clinical study (VOLTAIRE®-RL)

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Pages 545-548 | Received 02 Jan 2018, Accepted 01 May 2018, Published online: 15 May 2018

References

  • Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344(12):907–916.
  • FDA. Guidance for industry. Rheumatoid arthritis: developing drug products for treatment. [Internet]. US: Food and Drug Administration; 2013 [cited 2017 May 30]. Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM354468.pdf
  • 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 randomised, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects. Expert Opin Investig Drugs. 2016;25(12):1361–1370.
  • Cohen SB, Alonso-Ruiz A, Klimiuk PA, et al. Biosimilar Candidate BI 695501 and adalimumab reference product have similar efficacy and safety in patients with moderately-to-severely active rheumatoid arthritis (RA): 1-Year results from a Phase III study [abstract 2442]. Arthritis Rheumatol. 2017;69(suppl 10).
  • Van den Bemt BJ, Zwikker HE, van den Ende CH. Medication adherence in patients with rheumatoid arthritis: a critical appraisal of the existing literature. Expert Rev Clin Immunol. 2012;8(4):337–351.
  • Duffin KC, Bukhalo M, Bobonich MA, et al. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience. Med Devices (Auckl). 2016;9:361–369.

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