Global Biopharmaceutical Development, Sandoz International, Germany.
Clin Pharmacol Ther. 2013 Apr;93(4):315-7. doi: 10.1038/clpt.2013.17. Epub 2013 Jan 25.
Experts debate the clinical evidence standards needed to approve major manufacturing changes for biologics, biosimilars, and interchangeable biosimilars. As sponsors consider their development plans, the resource investment required to develop an analytically highly similar candidate must be balanced by regulatory relief for the clinical studies required to achieve the necessary indications for the marketed product. This article discusses biosimilarity and comparability as related scientific and regulatory concepts and the usefulness of clinical data for both.
专家就批准生物制品、生物类似药和可互换生物类似药的重大生产变更所需的临床证据标准展开了辩论。随着赞助商考虑其研发计划，为开发具有高度分析相似性的候选药物所需的资源投入必须与监管缓解相平衡，以实现上市产品所需的必要适应症。本文讨论了生物类似物和可比性作为相关的科学和监管概念，以及临床数据对两者的有用性。
