IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute , Milan , Italy.
Department of Biomedical Sciences, Humanitas University , Milan , Italy.
Expert Opin Biol Ther. 2019 Oct;19(10):1023-1030. doi: 10.1080/14712598.2019.1564033. Epub 2019 Jan 8.
: Biosimilars represent great potential in cost saving and re-investment opportunities in healthcare and allow patients greater access to effective mAbs. Infliximab biosimilars are successfully used in all indications for whom the reference product (RP) was approved. : In late 2018, adalimumab biosimilars will also be available in patients with inflammatory bowel disease (IBD). ABP501, BI 695501, GP2017, and SB5 have been approved by the EMA for the same indications of the reference product (RP, Humira®). Preclinical data show high similarity between all biosimilars and the RP. Clinical data in patients with rheumatoid arthritis and psoriasis also show no differences in terms of efficacy, safety, and immunogenicity. Data in IBD patients are still lacking. : Biosimilars of adalimumab appear to be clinically equivalent to the RP. Decisions based on choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, or choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IBD.
生物类似药具有巨大的成本节约潜力和医疗保健再投资机会，使更多患者能够获得有效的单克隆抗体。英夫利昔单抗生物类似药已成功用于所有已批准的参照产品（RP）适应证。
2018 年末，阿达木单抗生物类似药也将可用于炎症性肠病（IBD）患者。ABP501、BI 695501、GP2017 和 SB5 已获得 EMA 批准，用于与参照产品（RP，Humira®）相同的适应证。临床前数据显示，所有生物类似药与 RP 之间具有高度相似性。在类风湿关节炎和银屑病患者中的临床数据也显示在疗效、安全性和免疫原性方面无差异。IBD 患者的数据仍缺乏。
阿达木单抗生物类似药似乎在临床上与 RP 等效。基于选择理想患者接受阿达木单抗的生物类似药或转换为该生物类似药，或选择一种生物类似药与另一种相比，或在生物类似药之间交叉转换的决策，仍然是 IBD 领域的下一个挑战。
