First Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
Department of Gastroenterology, McGill University Health Center, Montreal, Canada.
Curr Pharm Des. 2019;25(1):13-18. doi: 10.2174/1381612825666190312112900.
The introduction of biological drugs has revolutionized the management of inflammatory bowel diseases (IBD), however, the increasing financial burden of biologicals on the health care system is alarming. Biosimilars are considered to be equivalent to the reference medicinal product (RMP) in terms of pharmacokinetic properties, clinical effectiveness and safety. CT-P13 infliximab was the first biosimilar to be approved by the regulatory authorities EMA and US FDA, and others are becoming increasingly available as patents expire on the RMP. Emerging data suggests that one-way switching from the RMP to an approved biosimilar is safe and acceptable, however data on multiple-switching, reversed switching, or cross-switching between biosimilars is scarce. Accumulating data on biosimilars led to an increased acceptance amongst physicians and their use can be expected to offer increased availability for patients, and also better control of economic sustainability. This review discusses the available data on clinical efficacy and safety of approved biosimilar agents, and assesses the current impact and future perspectives of biosimilars on the health care system.
生物药物的引入彻底改变了炎症性肠病（IBD）的治疗模式，然而，生物制剂给医疗保健系统带来的财政负担不断增加令人担忧。生物类似药在药代动力学特性、临床疗效和安全性方面被认为与参比药物（RMP）等效。依诺肝素是第一个获得欧洲药品管理局（EMA）和美国食品和药物管理局（US FDA）批准的生物类似药，随着 RMP 专利的到期，其他生物类似药也越来越多。有新数据表明，从 RMP 单向转换为已批准的生物类似药是安全且可以接受的，然而，关于生物类似药之间的多次转换、反向转换或交叉转换的数据很少。生物类似药相关数据的增加使医生更容易接受，预计它们的使用将为患者提供更多的可及性，并更好地控制经济可持续性。本文讨论了已批准的生物类似药在临床疗效和安全性方面的现有数据，并评估了生物类似药对医疗保健系统的当前影响和未来前景。
