CP-108 Biosimilars: What do clinicians actually think?

Abstract

BackgroundThe 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.PurposeThe 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 methodsA 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.Results36 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).ConclusionMajor 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 AcknowledgementsThanks to the medical staff.No conflict of interest.

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review

“…Twenty surveys met the inclusion criteria and were included in this systematic review ( Figure 1). The included studies originated from the United States of America [15][16][17] , Belgium 18,19 , France [20][21][22] , Germany 23,24 , Italy 25 , Ireland 26 , Malta 27 , Hungary 28 , and the United Kingdom (UK) 29 (Table 1).…”

“…Only half of respondents had actually prescribed biosimilars at the time of the survey. 22 In Barsell et al 15 (U.S., 2017), 62% of dermatologists had a basic understanding of biosimilars, 27% reported a complete understanding, and 11% reported that they have never heard of biosimilars. Of those who reported having a complete understanding of biosimilars, 21% incorrectly described a biosimilar as a generic copy of a biologic molecule.…”

“…Higher familiarity with biosimilars was reported by 97% of rheumatologists in Kellner et al 33 (EU, 2016), but only 48% correctly identified the EMA definition of a biosimilar. In Sidikou et al 22 (France 2016), 61% of physicians reported good biosimilar knowledge and 70% reported a high level of confidence for biosimilar use. Only half of respondents had actually prescribed biosimilars at the time of the survey.…”

“…Sixteen studies quantified clinicians' biosimilar prescribing habits. 15,17,[29][30][31][32][33][34]19,[21][22][23][24][25][26]28 In Danese et al 30 (EU, 2014), 61% of gastroenterologists felt little or no confidence in using biosimilars, 26% felt confident enough, 8% felt very confident, and 5% felt totally confident. When the survey was repeated one year after biosimilars became available in the EU, confidence had increased, as 19.5% of gastroenterologists felt little or no confidence in using biosimilars, 33.9% felt confident enough, 17.8% felt very confident, and 28.8% felt totally confident (EU, 2016).…”

“…In another 2016 French survey, 22% of physicians reported writing ≥ 1 biosimilar prescription/week, 30.5% between 6-to-12 biosimilar prescriptions/year, and 47% < 6 biosimilar prescriptions/year. 22 In Pasina et al 25 (Italy, 2016), 51% of clinicians prescribed biosimilars to biologic-naïve patients only, while 25% also prescribed biosimilars to patients with previous biologic exposure. Greater than 50% biosimilar prescribing was reported in Hallersten et al 32 (EU, 2016) and Kellner et al 33 (EU, 2016).…”