IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Via Manzoni 56, 20089 Rozzano, Milan, Italy.
Best Pract Res Clin Gastroenterol. 2014 Jun;28(3):465-71. doi: 10.1016/j.bpg.2014.04.006. Epub 2014 May 4.
The biologicals have led to dramatic changes in the management of immune-mediated diseases, and the subsequent development of their biosimilars may reduce the high costs of these agents. However, there remain concerns about the true equivalence of a biosimilar and its reference product, as well as around immunogenicity of these agents in IBD, although studies on rheumatoid arthritis support the similarity of biosimilars and their originators. Many of the biologicals are approved for multiple indications, but it is not always possible to extrapolate across indications for the corresponding biosimilars. For both reference agents and biosimilars, rare adverse events and long-term efficacy and safety can only be assessed through post marketing surveillance; therefore, particular emphasis should be placed on the traceability of these agents in clinical practice. Lastly, based on current data, biosimilars cannot be considered simple substitutes of reference products in IBD, unless demonstrated by well-designed randomized controlled trials.
生物制剂已经显著改变了免疫介导性疾病的治疗模式，其生物类似药的后续开发可能会降低这些药物的高昂费用。然而，人们仍然担心生物类似药与其参照产品的真正等效性，以及这些药物在炎症性肠病中的免疫原性，尽管类风湿关节炎的研究支持生物类似药与其原创药的相似性。许多生物制剂被批准用于多种适应证，但并不总是可以将相应的生物类似药适应证外推。对于参照药物和生物类似药，只有通过上市后监测才能评估罕见不良事件以及长期疗效和安全性；因此，应该特别重视这些药物在临床实践中的可追溯性。最后，根据现有数据，如果没有经过精心设计的随机对照试验证明，生物类似药不能被认为是炎症性肠病中参照产品的简单替代品。
