Danese Silvio, Fiorino Gionata, Michetti Pierre
IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy
Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy.
J Crohns Colitis. 2016 Nov;10(11):1362-1365. doi: 10.1093/ecco-jcc/jjw090. Epub 2016 Apr 25.
In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union.
A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected.
Out of the 118 responders, only 17% of responders had no access to biosimilars. Most responders regarded cost-sparing [92.4%] as the main advantage of biosimilars, considered immunogenicity [69%] to be their main concern, and estimated that post-marketing pharmacovigilance, well-designed randomized clinical trials and further studies of risk profile were needed [30.5%, 27%, 32.2%, respectively, a 30-40% reduction since 2013]. Only 35% of physicians think biosimilars should carry distinct International Nonproprietary Names, as compared with 66% in 2013, and 89.8% disagreed with automatic substitution of the originator with a biosimilar by a pharmacist. The originator and biosimilar were considered interchangeable by 44.4% of responders, as compared with 6% in 2013. Only 32.2% were against the extrapolation across indications, and only 25% would not extrapolate data across IBD. Finally, only 19.5% felt little or no confidence in the use of biosimilars, as compared with 63% in 2013.
IBD specialists are generally well informed and educated about biosimilars. Compared with in 2013, there are now fewer concerns and more confidence about their use in clinical practice.
2013年，一项欧洲克罗恩病和结肠炎组织（ECCO）调查显示，少数炎症性肠病（IBD）专家了解生物类似药的益处和问题且对此充满信心。我们旨在研究IBD专家在生物类似药于欧盟上市一年后的看法变化。
在ECCO网站上发布了一项包含14个问题的匿名调查。成员们应ECCO办公室邀请自愿参与调查并做出回应。还收集了有关性别、职位、国家以及生物制剂使用经验的信息。
在118名受访者中，只有17%的受访者无法使用生物类似药。大多数受访者认为节省成本（92.4%）是生物类似药的主要优势，将免疫原性（69%）视为主要担忧，并估计需要开展上市后药物警戒、精心设计的随机临床试验以及风险特征的进一步研究（分别为30.5%、27%、32.2%，自2013年以来减少了30 - 40%）。只有35%的医生认为生物类似药应使用不同的国际非专利名称，而2013年这一比例为66%，并且89.8%的人不同意药剂师自动用生物类似药替代原研药。44.4%的受访者认为原研药和生物类似药可互换，而2013年这一比例为6%。只有32.2%的人反对适应症外推，只有25%的人不会对炎症性肠病的数据进行外推。最后，只有19.5%的人对使用生物类似药几乎没有信心或完全没有信心相比，2013年这一比例为63%。
IBD专家对生物类似药总体上了解充分且接受了相关教育。与2013年相比，现在对其在临床实践中的使用担忧减少，信心增强。
