University of Toronto, Toronto, Canada.
Stat Med. 2013 Feb 10;32(3):434-41. doi: 10.1002/sim.5569. Epub 2012 Aug 22.
Interchangeability of drug products has very different features with small molecules and with biologicals. With small-molecule drugs, a statement of bioequivalence generally indicates therapeutic equivalence and interchangeability. In contrast, with the much more sensitive and complicated biological drugs, a declaration of biosimilarity emphatically does not imply that a patient could be switched from one product to another. Both formulations may be prescribed and administered to subjects who have not received yet the drug in any of its forms. However, regulatory agencies have been very cautious about enabling and permitting interchangeability. Notably, the Biologics Price Competition and Innovation Act of the USA sets very formidable and severe conditions for enabling the interchangeability of biological drug products. The background and conditions for the interchangeability of both small-molecule and biologic drug products are presented in detail.
药品的可互换性与小分子药物和生物制品有很大的不同。对于小分子药物，生物等效性声明通常表明治疗等效性和可互换性。相比之下，对于更为敏感和复杂的生物药物，生物类似药的声明并不能强调表明患者可以从一种产品转换到另一种产品。两种制剂都可以开给尚未以任何形式接受过该药物的患者使用。然而，监管机构对于启用和允许药物可互换性一直非常谨慎。值得注意的是，美国的《生物制品价格竞争与创新法案》为启用生物药物产品的可互换性设定了非常艰巨和严格的条件。详细介绍了小分子和生物药物产品可互换性的背景和条件。
