IBD Center, Humanitas Clinical and Research Centre, Milan, Italy.
J Crohns Colitis. 2013 Aug;7(7):586-9. doi: 10.1016/j.crohns.2013.03.011. Epub 2013 Apr 25.
Biologics have become key agents for the management of Crohn's disease and ulcerative colitis. Biosimilars are biological medicines similar to previously authorized biologics and are already available in some countries. This ECCO Position Statement defines the collective view of European specialist in inflammatory bowel disease (IBD) concerning biosimilars. Biosimilars are not comparable to generic small molecules, since both efficacy and toxicity are difficult to predict due to subtle molecular changes that can have profound effects on clinical efficacy and immunogenicity. Direct evidence of safety and benefit from clinical trials in IBD, post-marketing pharmacoviligance, and unequivocal identification of the product as a biosimilar should be requirements before approval. Switching from an established biologic to a biosimilar to save costs is likely to be as inappropriate and inefecctive as switching between current biologics that act on the same target, except when there is loss of response.
生物制剂已成为治疗克罗恩病和溃疡性结肠炎的关键药物。生物类似药是与先前批准的生物制剂相似的生物药物，在一些国家已经可用。本 ECCO 立场声明定义了欧洲炎症性肠病（IBD）专家对生物类似药的集体看法。生物类似药不能与普通小分子药物相媲美，因为由于微妙的分子变化，疗效和毒性都难以预测，这些变化可能对临床疗效和免疫原性产生深远影响。在 IBD 中进行临床试验、上市后药物警戒以及明确将产品鉴定为生物类似药的安全性和获益的直接证据应是获得批准的前提条件。为了节省成本而从已确立的生物制剂转换为生物类似药可能与在作用于相同靶点的当前生物制剂之间转换一样不适当和无效，除非出现应答丧失的情况。
