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[炎症性肠病(IBD)中的生物类似药:德国胃肠病学家的经验与看法]

[Biosimilars in Inflammatory Bowel Disease (IBD): Experiences and perceptions of german gastroenterologists].

作者信息

Bokemeyer Bernd, Dignaß Axel, Schreiber Stefan

机构信息

Gastroenterologische Gemeinschaftspraxis Minden, Minden.

Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt/Main.

出版信息

Z Gastroenterol. 2017 Apr;55(4):369-374. doi: 10.1055/s-0042-121520. Epub 2017 Jan 5.

Abstract

The European Medicines Agency (EMA) recently approved the first anti-TNF-alpha biosimilar for infliximab (CT-P13) (trade names: Inflectra and Remsima) in Germany. Over the past year, German gastroenterologists gained experience treating IBD-patients with infliximab biosimilars (IFX-biosimilars). To evaluate their experiences and opinions on biosimilars, we conducted a nationwide online survey among German gastroenterologists. Our results are based on the assessment of 449 questionnaires. Although 61 % of the participants had already prescribed IFX-biosimilars, about two thirds of these participating gastroenterologists with IFX-biosimilar prescription stated their experience as based on fewer than 10 IBD-patients treated with IFX-biosimilars. Only 15 % considered themselves to be very experienced with biosimilars. The lower price in comparison to the originator is seen as the most important advantage of biosimilars (71 %). More than two thirds of the survey participants requested specific gastroenterological trials and registries to increase the data available on biosimilars in IBD-patients (68 %).

摘要

欧洲药品管理局(EMA)最近在德国批准了首个英夫利昔单抗的抗TNF-α生物类似药(CT-P13)(商品名:Inflectra和Remsima)。在过去一年中,德国胃肠病学家积累了使用英夫利昔单抗生物类似药(IFX-生物类似药)治疗炎症性肠病(IBD)患者的经验。为了评估他们对生物类似药的经验和看法,我们在德国胃肠病学家中开展了一项全国性在线调查。我们的结果基于对449份问卷的评估。尽管61%的参与者已经开具过IFX-生物类似药的处方,但在这些开具过IFX-生物类似药处方的参与调查的胃肠病学家中,约三分之二表示他们治疗过的使用IFX-生物类似药的IBD患者不到10例。只有15%的人认为自己对生物类似药非常有经验。与原研药相比价格更低被视为生物类似药最重要的优势(71%)。超过三分之二的调查参与者要求开展特定的胃肠病学试验和登记,以增加IBD患者中生物类似药的可用数据(68%)。

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