Nikitina Victoria, Laurini Greta Santi, Montanaro Nicola, Motola Domenico
Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Via Irnerio 48, 40126 Bologna, Italy.
Alma Mater Studiorum University di Bologna, 40126 Bologna, Italy.
J Clin Med. 2025 Feb 28;14(5):1644. doi: 10.3390/jcm14051644.
: The advent of biosimilars has revolutionized the management of conditions like rheumatoid arthritis by offering cost-effective alternatives to expensive biologics. : This study aims to compare the post-marketing safety profiles of biosimilars used in rheumatology with their respective reference products (RPs). : Data were retrieved from EudraVigilance for biosimilars of adalimumab, etanercept, infliximab, and rituximab, and compared with their RPs. Our analysis focused on biosimilars authorized before 2021, using data from January 2021 to December 2023. We conducted a descriptive analysis of suspected adverse events, categorized using the Medical Dictionary for Regulatory Activities, and performed a comparative analysis using the reporting odds ratio to identify potential safety signals of disproportionate reporting. : We analyzed 75,327 reports, identifying 566,249 drug-event pairs. The results indicate that biosimilars have safety profiles largely comparable to their RPs. Female patients predominated in the reports, representing 69.4% of RPs and 56.9% of biosimilars. Notably, biosimilars demonstrated higher reporting rates for non-serious suspected adverse drug events (AEs), such as injection site pain, arthralgia, and fatigue. Specific AEs, including drug ineffectiveness and off-label use, were more frequent for infliximab and etanercept biosimilars, possibly reflecting real-world usage patterns and nocebo effects. Serious AEs, including malignancies and immunological reactions, were also noted, underscoring the necessity for ongoing monitoring. : Our findings suggest that biosimilars are safe alternatives to RPs, contributing to significant healthcare cost savings in the EU. This study underscores the need for ongoing pharmacovigilance and long-term safety research to validate the clinical use of biosimilars in rheumatology.
生物类似药的出现彻底改变了类风湿性关节炎等病症的治疗方式，为昂贵的生物制剂提供了经济高效的替代方案。本研究旨在比较风湿病学中使用的生物类似药与其各自的参照产品（RP）的上市后安全性概况。从欧洲药品不良反应数据库（EudraVigilance）中检索了阿达木单抗、依那西普、英夫利昔单抗和利妥昔单抗生物类似药的数据，并与它们的参照产品进行比较。我们的分析聚焦于2021年前获批的生物类似药，使用2021年1月至2023年12月的数据。我们对疑似不良事件进行了描述性分析，使用《监管活动医学词典》进行分类，并使用报告比值比进行比较分析，以识别不成比例报告的潜在安全信号。我们分析了75327份报告，确定了566249对药物 - 事件组合。结果表明，生物类似药的安全性概况与它们的参照产品基本相当。报告中女性患者占主导，在参照产品报告中占69.4%，在生物类似药报告中占56.9%。值得注意的是，生物类似药在非严重疑似药物不良事件（AE）方面的报告率较高，如注射部位疼痛、关节痛和疲劳。特定的不良事件，包括药物无效和超说明书用药，在英夫利昔单抗和依那西普生物类似药中更为常见，这可能反映了实际使用模式和安慰剂效应。还注意到了严重不良事件，包括恶性肿瘤和免疫反应，这凸显了持续监测的必要性。我们的研究结果表明，生物类似药是参照产品的安全替代方案，有助于在欧盟大幅节省医疗成本。本研究强调了持续开展药物警戒和长期安全性研究以验证生物类似药在风湿病学中临床应用的必要性。
