Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, O&N2, Herestraat 49, Box 521, 3000, Leuven, Belgium.
Department of Pfizer Innovative Health Medical Affairs, Pfizer S.A., Pleinlaan 17, 1050, Brussels, Belgium.
BioDrugs. 2017 Oct;31(5):447-459. doi: 10.1007/s40259-017-0244-3.
Among patients and rheumatologists, current knowledge and perception of biosimilars in comparison with originator biologics is unknown.
The aim of this study was to investigate this knowledge and perception in Belgian rheumatologists and rheumatoid arthritis (RA) patients.
Anonymous web surveys were conducted in Belgian RA patients (n = 121) and rheumatologists (n = 41) during the period January-March 2016. The surveys covered topics on knowledge, similarity, price, preference, interchangeability, extrapolation and switching. Descriptive and statistical analyses of responses were performed.
Familiarity with biosimilars was reported by 49% of patients, of whom 77% knew what biosimilars were. RA patients equally questioned the proven efficacy of originators and biosimilars in RA, as well as their side effects and suitability. Furthermore, RA patients questioned the safety of biosimilars more often than that of originators (35 vs. 20%, respectively; p = 0.0094). Rheumatologists, more so than patients, expressed concerns that there might be differences between originators and biosimilars in terms of quality, safety, and price (p = 0.0292, p < 0.0001, p = 0.0129, respectively). The opinions of rheumatologists on interchangeability and extrapolation of indications varied. The price of an originator contributed substantially to the medicine preference of rheumatologists (p = 0.0002), but not patients.
Our study showed that rheumatologists, more so than patients, were convinced that there can be differences between originators and biosimilars. Despite safety being the major concern of patients, patients trusted their physician's decision to start on or switch to a biosimilar. The evolution of the uptake of biosimilars in Belgium might thus depend mainly on the perception of physicians.
在患者和风湿病学家中,目前对生物类似药与原研生物制剂的了解和看法尚不清楚。
本研究旨在调查比利时风湿病学家和类风湿关节炎(RA)患者对这些知识和看法的了解情况。
2016 年 1 月至 3 月期间,在比利时 RA 患者(n=121)和风湿病学家(n=41)中进行了匿名网络调查。调查涵盖了对知识、相似性、价格、偏好、可互换性、外推和转换等主题的看法。对回复进行了描述性和统计分析。
49%的患者熟悉生物类似药,其中 77%的患者知道什么是生物类似药。RA 患者同样质疑原研药和生物类似药在 RA 中的疗效以及它们的副作用和适用性。此外,RA 患者比风湿病学家更频繁地质疑生物类似药的安全性,而非原研药(分别为 35%和 20%;p=0.0094)。与患者相比,风湿病学家更担心原研药和生物类似药在质量、安全性和价格方面可能存在差异(p=0.0292,p<0.0001,p=0.0129)。风湿病学家对可互换性和适应症外推的看法存在差异。原研药的价格对风湿病学家的药物偏好有很大影响(p=0.0002),但对患者没有影响。
我们的研究表明,与患者相比,风湿病学家更相信原研药和生物类似药之间可能存在差异。尽管安全性是患者的主要关注点,但患者信任医生决定开始使用或转换为生物类似药的决策。因此,比利时生物类似药的使用情况的发展可能主要取决于医生的看法。