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CP-108 Biosimilars: What do clinicians actually think?
  1. O Sidikou,
  2. P Mondoloni,
  3. B Leroy,
  4. C Renzullo,
  5. J Coutet,
  6. JF Penaud
  1. Centre Hospitalier William Morey, Pharmacie, Chalon Sur Saône Cedex, France

Abstract

Background The expiry of patents for infliximab in Europe coincides with the arrival on the market of new biosimilars with potential savings. However, many clinicians are reluctant to consider biosimilars as a treatment option for their patients.

Purpose The aim of this study was to evaluate concerns raised about biosimilars in the medical community in our hospital in order to reference infliximab biosimilars.

Material and methods A questionnaire with different items was put online: knowledge about the regulation of biosimilars in France, the degree of confidence in biosimilars, existence of high level evidence studies on the safety of biosimilars, and the acceptance of prescription and substitution.

An item was used to evaluate the prescription frequency of biosimilars: regular prescribers (more than 1 prescription/week), occasional prescribers (between 6 and 12 prescriptions/year) and potential prescribers (<6 prescriptions/year). Comparison between prescriber groups was performed using Fisher’s exact test.

Results 36 prescribers responded to the survey. 47% (n = 17) were potential prescribers, 30.5% (n = 11) were occasional prescribers and 22% (n = 8) were regular prescribers. 61% (n = 22) had a good knowledge of the regulation of biosimilars. The degree of confidence was high for 70% (n = 25) of prescribers. However, 53% (n = 19) emphasised the lack of high level evidence for safety. 64% (n = 23) of prescribers were willing to prescribe a biosimilar and 50% (n = 18) to authorise substitution in patients already being treated with the originator product. The refusal rate for substitution seemed to be significantly different depending on the prescribing habits (p = 0.031). 75% (n = 6) of regular prescribers refused a substitution, while the refusal rate was 18% (n = 2) among occasional prescribers and 58.8% (n = 10) among potential prescribers. There were no statistically significant differences between prescribers groups about confidence level (p = 0.118).

Conclusion Major concerns voiced about biosimilars in this survey related to their pharmaceutical quality, safety (especially immunogenicity), efficacy (particularly in extrapolated indications) and interchangeability with the originator product. However, the acceptance of biosimilars in our hospital seems to be high. This allows pharmacists to initiate a process introducing infliximab biosimilars.

References and/or Acknowledgements Thanks to the medical staff.

No conflict of interest.

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