Organización Médica de Investigación, Buenos Aires, Argentina.
Rheumatology Unit, Department of Internal Medicine, Federal University of Paraná, Curitiba, PR, Brazil.
Drugs. 2021 Nov;81(16):1859-1879. doi: 10.1007/s40265-021-01610-1. Epub 2021 Oct 27.
Over time, clinicians have become increasingly comfortable embracing the prescription of biosimilars-highly similar versions of innovator or reference biological agents-for their patients with inflammatory diseases. Although a switch from a reference product to a licensed biosimilar version (or vice versa) is a medical decision robustly supported by the stepwise accumulation of clinical trial evidence concerning comparable safety, immunogenicity, and efficacy between these products, a switch from one biosimilar to another biosimilar of the same reference product, or a cross-switch, is not. Similarity among biosimilars of a reference product is not a regulatory agency concern and therefore is unlikely to be investigated in randomized controlled trials in the foreseeable future. Yet in clinical practice, across a diverse range of patients, the option to cross-switch from one biosimilar to another can and does arise for valid reasons such as convenience or tolerability issues, or driven by third parties (e.g., payers). In the absence of clinical trial data, clinicians must attempt to objectively evaluate the emerging real-world cross-switching evidence within the context of what is known about the science underpinning a designation of biosimilar. That knowledge then needs to be integrated with what clinicians know about their patients and their disease on a case-by-case basis. This review aims to consolidate relevant emerging real-world data and other key information about biosimilar-to-biosimilar cross-switching for prescribing clinicians. In the absence of clear clinical guidelines addressing this topic at present, this review may serve to facilitate discretionary and educated treatment decision making.
随着时间的推移，临床医生越来越愿意为患有炎症性疾病的患者开处生物类似药——与创新药或参照生物制剂高度相似的药物。虽然从参照产品转换为已许可的生物类似药（或反之亦然）是一个医疗决策，该决策得到了关于这些产品之间安全性、免疫原性和疗效可比性的临床试验证据逐步积累的有力支持，但从一种生物类似药转换为同一参照产品的另一种生物类似药，即交叉转换，却并非如此。参照产品的生物类似药之间的相似性并不是监管机构关注的问题，因此不太可能在可预见的未来在随机对照试验中进行调查。然而，在临床实践中，由于便利性或可耐受性问题或第三方（如支付方）的驱动，跨越多种患者，确实存在从一种生物类似药转换为另一种生物类似药的交叉转换的选择。在缺乏临床试验数据的情况下，临床医生必须尝试在对支撑生物类似药指定的科学有一定了解的背景下，客观地评估新兴的真实世界交叉转换证据。然后，这些知识需要与临床医生根据具体情况对其患者及其疾病的了解相结合。本综述旨在为开处方的临床医生整合有关生物类似药交叉转换的相关新兴真实世界数据和其他关键信息。鉴于目前没有明确的针对该主题的临床指南，本综述可能有助于做出自由裁量和有教育意义的治疗决策。
