Chang Shannon, Hanauer Stephen
New York University Langone Medical Center, NY, USA.
Northwestern University Feinberg School of Medicine, 676 N. St Clair, Suite 1400, Chicago, IL, 60611, USA.
Curr Treat Options Gastroenterol. 2017 Mar;15(1):53-70. doi: 10.1007/s11938-017-0122-6.
Infliximab and adalimumab biosimilars have been approved by the FDA and European Medicines Agency and have already been introduced to the international market. Availability into the US market is imminent. Biosimilars are highly similar to the reference biologic product but should not be referred to as, nor equated with, generic medications as no two biosimilars can ever be identical. Regulatory pathways for biosimilar approval consider the totality of evidence for biosimilar approvals, but the preponderance of development relies on analytic and functional testing and allows extrapolation between indications to reduce the financial burden of completing comparative clinical trials for each indication. Neither CT-P13 (infliximab biosimilar) nor ABP 501 (adalimumab biosimilar) was clinically tested in patients with inflammatory bowel disease prior to being submitted for approval by regulatory agencies. The body of available evidence suggests that these drugs will perform similarly to their originators. The pathway for interchangeability of biosimilars has yet to be clarified by federal regulators and currently remains determined by states within the USA. However, preliminary data suggests that switching from originator to biosimilar is safe with minimal differences in clinical efficacy.
英夫利昔单抗和阿达木单抗生物类似药已获美国食品药品监督管理局（FDA）和欧洲药品管理局批准，并已进入国际市场。进入美国市场也指日可待。生物类似药与参比生物制品高度相似，但不应被称为仿制药，也不能与仿制药等同，因为没有两种生物类似药会完全相同。生物类似药的批准监管途径会考虑生物类似药批准的全部证据，但大部分研发依赖于分析和功能测试，并允许在不同适应症之间进行外推，以减轻针对每个适应症完成对比临床试验的经济负担。CT-P13（英夫利昔单抗生物类似药）和ABP 501（阿达木单抗生物类似药）在提交监管机构批准之前，均未在炎症性肠病患者中进行临床试验。现有证据表明，这些药物的表现将与原研药相似。生物类似药的可互换途径尚未得到联邦监管机构的明确，目前仍由美国各州自行决定。然而，初步数据表明，从原研药转换为生物类似药是安全的，临床疗效差异极小。
