Duke University School of Medicine, Durham, NC, U.S.A.
Stat Med. 2013 Feb 10;32(3):370-81. doi: 10.1002/sim.5571. Epub 2012 Aug 30.
The problem for assessing biosimilarity and drug interchangeability of follow-on biologics (biosimilar products) is studied. Unlike the generic products, the development of biosimilar products is much more complicated because of fundamental differences in functional structures and manufacturing processes. As a result, the criteria and standard methods for the design and analysis of bioequivalence assessment of generic drug products may not be directly applicable to assessing biosimilarity of biosimilar products. In this article, we provide some scientific considerations for criteria, design, and analysis regarding the assessment of biosimilarity and drug interchangeability of biosimilar products. In addition, we discuss scientific and practical issues raised at the 2010 FDA public hearing and the 2011 FDA public meeting on biosimilar products.
本研究旨在探讨评估后续生物仿制药（生物类似药）的生物相似性和药物可互换性的问题。与仿制药不同，生物类似药的开发由于功能结构和制造工艺的根本差异而更加复杂。因此，用于设计和分析仿制药生物等效性评估的标准和方法可能不适用于评估生物类似药的生物相似性。本文提供了一些关于评估生物类似药的生物相似性和药物可互换性的标准、设计和分析的科学考虑因素。此外，还讨论了在 2010 年 FDA 公开听证会和 2011 年 FDA 关于生物类似药的公开会议上提出的科学和实际问题。
