Omair Mohammed A, Almadany Rana, Omair Maha A, Al Rayes Hanan, Almalag Haya M, Alshamsan Aws
Rheumatology Unit, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.
Saudi Food and Drug Authority, Saudi Arabia.
Saudi Pharm J. 2022 Jan;30(1):39-44. doi: 10.1016/j.jsps.2021.10.012. Epub 2021 Dec 21.
The aim of this study was to evaluate rheumatologists' perceptions of biosimilar biologics and Non-Medical Switching (NMS).
A cross-sectional survey was conducted among registered members of the Saudi Society for Rheumatology. The questionnaire focused on biosimilars and NMS. Logistic regression was performed to ascertain the effect of demographics and practice characteristics on the use of biosimilars and NMS.
Out of 249 SSR members, 143 completed the survey, generating a response rate of 57.4%. Of those (59.44%) were men with a mean (±SD) age and years of practice of 42.3 ± 9.13 and 10.3 ± 8.9, respectively. Rheumatologists managing adult patients (81.82%) and Ministry of Health practice (43.36 %) were the majority of respondents. Previous experience in prescribing a biosimilar was reported by 43 (30.07%) participants, with a higher probability among women (p = 0.015). A total of 26 (18.18%) participants had performed NMS on eligible patients. Adequate knowledge on biosimilars was reported by 69 (48.25%) participants. The adequacy of evidence to grant biosimilar approval for the studied indication and extrapolation to treat other conditions was reported by 88 (61.5%) and 69 (48.3%), respectively. The concept of was well understood by 37.1%. Biosimilars had been previously used by 43 (30.07) participants in their practice. NMS had been attempted by 26 (18.18), while 86 (60.1%) participants believed that NMS might harm patients.
There is a clear knowledge gap about the biosimilar approval process among adult and pediatric rheumatologists who took part in the survey. In addition, a large number of participants reported having negative opinions about NMS. There is a need to organize SSR-led educational activities, and develop national guidelines regarding biosimilars and NMS.
本研究旨在评估风湿病专家对生物类似药和非医学换药(NMS)的看法。
对沙特风湿病学会的注册会员进行了一项横断面调查。问卷聚焦于生物类似药和非医学换药。进行逻辑回归以确定人口统计学和执业特征对生物类似药和非医学换药使用的影响。
在249名沙特风湿病学会会员中,143人完成了调查,回复率为57.4%。其中(59.44%)为男性,平均(±标准差)年龄和执业年限分别为42.3±9.13岁和10.3±8.9年。管理成年患者的风湿病专家(81.82%)和在卫生部执业的专家(43.36%)占受访者的大多数。43名(30.07%)参与者报告有使用生物类似药的既往经验,女性的可能性更高(p = 0.015)。共有26名(18.18%)参与者对符合条件的患者进行了非医学换药。69名(48.25%)参与者报告对生物类似药有足够的了解。分别有88名(61.5%)和69名(48.3%)参与者报告有足够的证据批准所研究适应症的生物类似药并外推用于治疗其他病症。37.1%的人对该概念理解良好。43名(30.07%)参与者在其执业中曾使用过生物类似药。26名(18.18%)曾尝试过非医学换药,而86名(60.1%)参与者认为非医学换药可能会伤害患者。
参与调查的成年和儿科风湿病专家对生物类似药批准过程存在明显的知识差距。此外,大量参与者报告对非医学换药持负面看法。有必要组织由沙特风湿病学会牵头的教育活动,并制定关于生物类似药和非医学换药的国家指南。