Abstract：
BACKGROUND: Bioequivalence testing for locally acting gastrointestinal drugs is a challenging issue for both regulatory authorities and pharmaceutical industries. The international regulatory framework has been characterized by the lack of specific bioequivalence tests that has generated a negative impact on the market competition and drug use in clinical practice. Areas covered: This review article provides an overview of the European Union and United States regulatory frameworks on bioequivalence criteria for locally acting gastrointestinal drugs, also discussing the most prominent scientific issues and advances that has been made in this field. A focus on oral modified release mesalamine formulations will be also provided, with practical examples of the regulatory pathways followed by pharmaceutical companies to determine bioequivalence. Expert commentary: The development of a scientific rationale to demonstrate bioequivalence in this field has been complex and often associated with uncertainties related to scientific and regulatory aspects. Only in recent years, thanks to advanced knowledge in this field, the criteria for bioequivalence assessment are undergoing substantial changes. This new scenario will likely result in a significant impact on pharmaceutical companies, promoting more competition through a clearer regulatory approach, conceived for streamlining the demonstration of therapeutic equivalence for locally acting gastrointestinal drugs.
摘要：
背景：对于监管当局和制药行业来说，局部作用胃肠道药物的生物等效性测试是一个具有挑战性的问题。国际监管框架的特点是缺乏特定的生物等效性测试，这对市场竞争和临床实践中的药物使用产生了负面影响。涵盖的领域：这篇综述文章概述了欧盟和美国关于局部作用胃肠道药物生物等效性标准的监管框架，还讨论了该领域最突出的科学问题和进展。还将提供对口服改性释放美沙拉嗪制剂的关注，以及制药公司确定生物等效性的监管途径的实际例子。专家评论：证明该领域生物等效性的科学原理的发展是复杂的，并且通常与科学和监管方面的不确定性有关。只是在最近几年,多亏了这个领域的先进知识，生物等效性评估的标准正在发生重大变化.这种新情况可能会对制药公司产生重大影响，通过更清晰的监管方法促进更多竞争，构思用于简化局部作用胃肠道药物的治疗等效性证明。
