Bokemeyer Bernd, Dignaß Axel, Schreiber Stefan
Gastroenterologische Gemeinschaftspraxis Minden, Minden.
Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt/Main.
Z Gastroenterol. 2017 Apr;55(4):369-374. doi: 10.1055/s-0042-121520. Epub 2017 Jan 5.
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 %).
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%）。
