Research Centre for Pharmaceutical Care and Pharmaco-economics, Faculty of Pharmaceutical Sciences, Katholieke Universiteit Leuven, Onderwijs en Navorsing 2, Herestraat 49, P.O. Box 521, 3000 Leuven, Belgium.
Target Oncol. 2012 Dec;7(4):227-31. doi: 10.1007/s11523-011-0192-7. Epub 2012 Jan 17.
This article discusses specific issues related to the market access of biosimilars. Biopharmaceuticals are complex molecules produced by living cells. Copies of these medicines, called biosimilars, are not identical to their reference medicine and therefore specific regulatory requirements apply. When considering the use of biosimilars, the question of the degree of comparability between a biosimilar and the reference biopharmaceutical needs to be considered for registration, pricing and reimbursement purposes in addition to the cost issue. To date, many key concepts (like clinically meaningful differences) remain undefined and the question of the degree of comparability is not yet resolved.
本文讨论了与生物类似药市场准入相关的具体问题。生物制药是由活细胞生产的复杂分子。这些药物的仿制药称为生物类似药，它们与参照药物并不完全相同，因此适用特定的监管要求。在考虑使用生物类似药时，除了成本问题外，还需要考虑其与参照生物制药在注册、定价和报销方面的可比性程度。迄今为止，许多关键概念（如具有临床意义的差异）仍未定义，可比性程度的问题也尚未解决。
