Woodcock Janet, Griffin Joseph, Behrman Rachel, Cherney Barry, Crescenzi Terrie, Fraser Blair, Hixon Dena, Joneckis Christopher, Kozlowski Steven, Rosenberg Amy, Schrager Lewis, Shacter Emily, Temple Robert, Webber Keith, Winkle Helen
Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, USA.
Nat Rev Drug Discov. 2007 Jun;6(6):437-42. doi: 10.1038/nrd2307.
The scientific and regulatory issues that are associated with the possible introduction of 'follow-on' versions of protein drug products are the topic of considerable debate at present. Because of the differences between protein drug products and small-molecule drugs, the development of follow-on versions of protein products presents more complex scientific challenges than those presented by the development of generic versions of small-molecule drugs. Here, with a view to illustrating the Food and Drug Administration's (FDA's) scientific reasoning and experience in this area, we discuss past examples of the FDA's actions involving the evaluation of various types of follow-on and second-generation protein products and within-product manufacturing changes. The FDA believes its evaluation of the safety and effectiveness of follow-on protein products will evolve as scientific and technological advances in product characterization and manufacturing continue to reduce some of the complexity and uncertainty that are inherent in the manufacturing of protein products.
目前，与蛋白质药品“后续”版本的可能引入相关的科学和监管问题是相当多辩论的主题。由于蛋白质药品与小分子药物之间存在差异，蛋白质产品后续版本的开发比小分子药物仿制药的开发面临更复杂的科学挑战。在此，为了说明美国食品药品监督管理局（FDA）在这一领域的科学推理和经验，我们讨论FDA过去涉及评估各类后续和第二代蛋白质产品以及产品内部制造变更的行动示例。FDA认为，随着产品特性鉴定和制造方面的科学技术进步不断降低蛋白质产品制造中固有的一些复杂性和不确定性，其对后续蛋白质产品安全性和有效性的评估也将不断发展。
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