Background Regulations surrounding clinical trials, manufacturing and commercialization of biosimilars is evolving. Potential barriers to biosimilar adoption in the real-world warrant scrutiny to enable patient access to these medicines.
Objectives To assess the relationship between duration of rheumatology practice experience and rheumatologist perception towards biosimilars and the likelihood of use of biosimilars to manage Rheumatoid Arthritis (RA) patients in the European Union (EU), Brazil, Japan and China.
Methods A multi-country cross-sectional survey was conducted in top-5 EU countries (UK/Germany/Spain/France/Italy), Brazil, Japan and China in April/May 2013 using an online physician panel in the respective geographies; rheumatologists were randomly selected for survey participation to be geographically representative in select countries/regions. Surveys assessed the rheumatologist perceptions of biosimilars in terms of factors that would prevent them from using biosimilars among their biologic-eligible RA patients, and their likelihood of use of biosimilars. Summary statistics are reported across the markets, stratified by years of rheumatology-practice-experience.
Results 173 rheumatologists participated in the survey (5EU-58%, Brazil-23%, Japan-11% and China-9%); years of experience practicing rheumatology (across the markets) was: ≤10yrs: 26%, 11-20yrs: 42%, >20yrs: 32%. Mean RA patient-volume/year based on rheumatology-practice-experience was: ≤10yrs: 264, 11-20yrs: 323, >20yrs: 270. Likelihood of prescribing a biosimilar product to eligible RA patients differed by rheumatology-practice-experience (≤10yrs/11-20yrs/>20yrs): definitely - 13%/13%/5%; highly likely - 27%/42%/39%; may be/not sure - 44%/36%/38%; less/not likely - 16%/10%/18%. Perceived duration of use of biosimilars in a small group of patients before prescribing it in larger scale was (by rheumatology-practice-experience ≤10yrs/11-20yrs/>20yrs): 1-2yrs: 53%/56%/43%, 3-5yrs: 16%/11%/14%, 6-10yrs: 2%/1%/2%, >10yrs: 4%/4%/5%; not-sure: 24%/28%/36%. Key factors noted by rheumatologists that would prevent them from using biosimilars were (by rheumatology-practice-experience ≤10yrs/11-20yrs/>20yrs): Doubts in similarity to original molecule (56%/63%/59%), inadequate safety/efficacy profile/data (47%/57%/52%), lack of long-term data (42%/39%/57%), lack of national guidelines recommending the use of biosimilars (40%/38%/34%), lack of data from local country/market (40%/31%/25%), lack of trust/confidence in manufacturer (24%/25%/27%).
Conclusions Rheumatologists perceptions varied based on their practice-experience; among those with ≤10yrs of practice-experience, higher proportion stated being doubtful or less/not likely of prescribing biosimilars to eligible RA patients, and a higher proportion of them cited national treatment guidelines and lack of data from local country/market among key reasons preventing biosimilar use. Conversely, among those with >20yrs of practice experience, a lower proportion cited lack of treatment guidelines and lack of data from local country/market as key reasons preventing biosimilar use.
Disclosure of Interest None declared