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欧洲关于用于治疗炎症性肠病的生物类似药的观点与历史

The European Perspective and History on Biosimilars for the Treatment of Inflammatory Bowel Diseases.

作者信息

Solitano Virginia, D'Amico Ferdinando, Da Rio Leonardo, Peyrin-Biroulet Laurent, Danese Silvio

机构信息

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.

出版信息

Crohns Colitis 360. 2021 Feb 23;3(1):otab012. doi: 10.1093/crocol/otab012. eCollection 2021 Jan.

Abstract

With the expiration of biologics' patents, biosimilars entered the market as a promising opportunity to reduce health-care costs in the field of inflammatory bowel diseases. Although biosimilars were initially poorly accepted, the growing evidence about their efficacy and safety has changed this situation, resulting in their widespread use. However, there is still an unmet need of improving patients' education about biosimilars to minimize nocebo responses and to accept nonmedical switching. Looking to the future, the use of recently authorized adalimumab biosimilars and the first attempts of adopting different strategies of switching (eg, cross-, multiple-) will fill some residual knowledge gaps.

摘要

随着生物制剂专利的到期,生物类似药作为降低炎症性肠病领域医疗成本的一个有前景的机会进入市场。尽管生物类似药最初的接受度较低,但越来越多关于其疗效和安全性的证据改变了这种情况,导致它们被广泛使用。然而,在提高患者对生物类似药的认知以尽量减少反安慰剂反应并接受非医学换药方面,仍存在未满足的需求。展望未来,最近获批的阿达木单抗生物类似药的使用以及首次尝试采用不同的换药策略(如交叉、多重换药)将填补一些剩余的知识空白。

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