The clinical safety and efficacy of rituximab biosimilars compared to the reference rituximab (Mabthera) have been well established in randomized trials. However, concerns persist regarding the safety of changing from the reference product to biosimilars, and particularly between different biosimilars. This prospective multicenter observational study was conducted in 13 oncohematology units of eight Italian regions. The study included 800 patients with non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who received rituximab between March 2018 and June 2022. To minimize survivorship bias, only newly diagnosed patients (i.e., those without prior rituximab treatment) were included in the analysis of adverse drug reactions (ADRs). Thus, this study focused on 505 incident cases (79.8% of the initial cohort) from 13 centers. A total of 3681 rituximab infusions were administered, and 16.8% of the patients experienced at least one ADR. These were observed most frequently during the first infusion (44 patients, 52%) and the second infusion (17 patients, 20%). The most frequent reactions were general disorders and administration site conditions (n. 50, 8% serious). These findings support the clinical safety of rituximab biosimilars and suggest that switching between biosimilars does not increase the risk of adverse events. This evidence may alleviate concerns about biosimilar use, potentially leading to broader acceptance and reduced healthcare costs.
利妥昔单抗生物类似药相较于参照药利妥昔单抗（美罗华）的临床安全性与有效性已在随机试验中得到充分验证。然而，从参照药转换为生物类似药，尤其是不同生物类似药之间的转换，其安全性仍持续引发关注。本研究在意大利八个大区的13个血液肿瘤中心开展了一项前瞻性多中心观察性研究。研究纳入了2018年3月至2022年6月期间接受利妥昔单抗治疗的800例非霍奇金淋巴瘤（NHL）或慢性淋巴细胞白血病（CLL）患者。为最大程度减少生存偏倚，仅新诊断患者（即既往未接受过利妥昔单抗治疗者）被纳入药品不良反应（ADRs）分析。因此，本研究最终聚焦于来自13个中心的505例新发病例（占初始队列的79.8%）。研究期间共进行了3681次利妥昔单抗输注，16.8%的患者至少经历了一次ADR。这些反应最常发生于首次输注（44例患者，占52%）和第二次输注（17例患者，占20%）。最常见的反应为全身性反应及给药部位状况（共50例，其中8%为严重反应）。这些发现支持利妥昔单抗生物类似药的临床安全性，并提示生物类似药间的转换不会增加不良事件风险。该证据可能缓解对生物类似药使用的担忧，有望推动其更广泛的应用并降低医疗成本。
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