Qahtani Mohammed Al, Al-Jedai Ahmed, Wertheimer Albert
Security Forces Hospital- Dammam, KSA.
Saudi Arabia Deputy of Therapeutic Affairs, Colleges of Medicine and Pharmacy, AL Faisal University, Riyadh, KSA.
Innov Pharm. 2024 Nov 26;15(4). doi: 10.24926/iip.v15i4.6371. eCollection 2024.
Biosimilars are safe and effective treatments for chronic diseases, including cancer and rheumatoid arthritis. The Saudi Food and Drug Authority (SFDA) oversees the quality and registration of biosimilars in Saudi Arabia. However, disparities among regulatory authorities such as the lack of guidelines for biosimilars in rheumatology affect healthcare providers' perceptions, leading to hesitancy in switching from reference products to biosimilars. This study aimed to explore the perceptions of Saudi healthcare professionals regarding biosimilars. A convenience sample of 87 participants (75 pharmacists and 12 physicians) was analyzed. The data were collected between December 2022 and February 2023. A logistic regression model was used to predict the intention toward biosimilars. Years of practice among physicians significantly influenced their intention to prescribe biosimilars. Positive correlations were also observed between intentions towards prescription and beliefs regarding the safety and efficacy of biosimilars. Pharmacists' authority and knowledge of biosimilars correlated with their intention to substitute or dispense them. However, the logistic regression analysis indicated that behavioral, normative, and control beliefs were not significant predictors of the intention to prescribe or substitute biosimilars in either group. Highlighting the significance of continuing education and coordinating efforts in the international harmonization of biosimilar guidelines, as well as education for healthcare professionals, is required for addressing clinical concerns and enhancing confidence in biosimilars.
生物类似药是治疗包括癌症和类风湿性关节炎在内的慢性病的安全有效药物。沙特食品药品管理局（SFDA）负责监管沙特阿拉伯生物类似药的质量和注册。然而，监管机构之间存在差异，例如风湿病领域缺乏生物类似药指南，这影响了医疗服务提供者的认知，导致他们在从参比产品转向生物类似药时犹豫不决。本研究旨在探讨沙特医疗专业人员对生物类似药的看法。分析了87名参与者（75名药剂师和12名医生）的便利样本。数据收集于2022年12月至2023年2月之间。使用逻辑回归模型预测对生物类似药的意向。医生的从业年限显著影响他们开具生物类似药的意向。在处方意向与对生物类似药安全性和有效性的信念之间也观察到正相关。药剂师对生物类似药的权限和知识与他们替换或配发生物类似药的意向相关。然而，逻辑回归分析表明，行为、规范和控制信念在两组中均不是开具或替换生物类似药意向的显著预测因素。强调继续教育以及在生物类似药指南国际协调方面协同努力的重要性，同时也需要对医疗专业人员进行教育，以解决临床问题并增强对生物类似药的信心。
