将生物类似药引入当前炎症性肠病治疗算法

J. Allport
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引用次数: 0

摘要

生物仿制药遵循严格的监管审批途径,旨在收集和审查生物仿制药与参考生物之间的非临床分析可比性练习以及临床I期和III期研究的全部证据。一旦欧洲药品管理局(EMA)对生成的全部证据给出了肯定的意见,该机构可以将生物仿制药的临床数据从研究生物仿制药的适应症推断到参考生物被批准的其他适应症。这一步骤的先决条件是在研究的临床III期人群中有令人信服的生物相似性证明,该生物相似性对检测疗效、安全性或免疫原性方面的潜在临床相关差异具有适当的敏感性。该调控途径用于所有目前可用的生物仿制药,包括SB2 (Flixabi®),这是一种最近批准的生物仿制药,获准用于其参考生物英夫利昔单抗(Remicade®)的所有适应症,包括炎症性肠病(IBD)。此外,SB2在46项理化和23项生物试验中进行了强有力的非临床评估,一项I期研究证明了SB2与参考药物英夫利昔单抗之间的药代动力学等效。此外,一项针对中重度类风湿关节炎(RA)患者的III期研究显示,SB2在第30周的主要终点——美国风湿病学会20%改善(ACR20)缓解率方面与英夫利昔单抗相当,在54周的安全性和免疫原性方面也相当。通过抗药抗体(ADA)状态对治疗中出现的不良事件(teae)进行的额外分析表明,在第54周,两个治疗组的teae发生率相当。在持续接受SB2或参考英夫利昔单抗的患者和从参考英夫利昔单抗过渡到SB2的患者之间,ACR反应率、安全性和ADAs发生率也保持可比性,持续到第78周。生物仿制药在IBD治疗中占有重要地位。在克罗恩病(CD)或溃疡性结肠炎患者中增加生物仿制药的使用可能会降低成本,扩大符合条件的患者获得生物治疗的机会,并改善总体健康结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Introducing Biosimilars into Current Inflammatory Bowel Disease Treatment Algorithms
Biosimilars follow a rigorous regulatory approval pathway designed to collect and review the totality of evidence from non-clinical analytical comparability exercises as well as clinical Phase I and III studies between the biosimilar and the reference biological. Once the European Medicines Agency (EMA) has given a positive opinion on the generated totality of evidence, the agency may extrapolate the biosimilar’s clinical data from the indication in which the biosimilar was studied to other indications for which the reference biological was approved. A prerequisite for this step is a convincing demonstration of biosimilarity within a studied clinical Phase III population that is suitably sensitive to detect potential clinically relevant differences in efficacy, safety, or immunogenicity. This regulatory pathway was used for all currently available biosimilars including SB2 (Flixabi®), a recently approved biosimilar that is licensed for use across all indications approved for its reference biologic infliximab (Remicade®), including inflammatory bowel disease (IBD). Further to robust non-clinical evaluations of SB2 in 46 physicochemical and 23 biological assays, a Phase I study demonstrated pharmacokinetic equivalence between SB2 and reference infliximab. Furthermore, a Phase III study performed in patients with moderate-to-severe rheumatoid arthritis (RA) — a scientifically appropriate, sensitive patient population — showed that SB2 was equivalent to infliximab in terms of its primary endpoint, American College of Rheumatology 20% improvement (ACR20) response rate at Week 30, and comparable with regard to safety and immunogenicity up to Week 54. Additional analyses of treatment-emergent adverse events (TEAEs) by anti-drug antibody (ADA) status up to Week 54 demonstrated a comparable incidence of TEAEs in both treatment arms. The ACR response rates, safety, and incidence of ADAs remained comparable also in the transition extension period up to Week 78 between patients who continued to receive either SB2 or reference infliximab, and patients who transitioned from reference infliximab to SB2. Biosimilars have an important place in the treatment of IBD. Increased use of biosimilars in patients with Crohn’s disease (CD) or ulcerative colitis is likely to reduce costs, expand access of eligible patients to biologic therapy, and improve overall health outcomes.
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