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Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching
  1. Fabrizio Cantini1,
  2. Maurizio Benucci2
  1. 1 Department of Rheumatology, Azienda USL Toscana Centro, Hospital of Prato, Prato, Italy
  2. 2 Rheumatology Clinic, Azienda USL Toscana Centro, Nuovo S Giovanni di Dio Hospital, Florence, Italy
  1. Correspondence to Dr Fabrizio Cantini, Department of Rheumatology, Azienda USL Toscana Centro, Hospital of Prato, Prato 59100, Italy; fbrzcantini{at}

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We read with great interest the recently published results from DANBIO registry on switching from originator etanercept (ETA) to the biosimilar SB4.1 The study includes a really impressive number of patients who underwent mandatory switching to SB4, and at first glance the results show a good evidence of efficacy and safety of the procedure. However, in our opinion, how these results may be applied on non-medical switching strategy is rather questionable. A careful reading of the paper raises several concerns related to the demographic and clinical characteristics of switchers and non-switchers, and to the timing of clinical evaluations that may generate misleading biases.

First, switchers had longer previous ETA treatment duration and fewer previous bDMARDs compared with non-switchers suggesting a less severe disease. This seems to be confirmed by the baseline lower disease activity both …

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  • Handling editor Josef S Smolen

  • Contributors FC and MB equally contributed to write the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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