Cytovance Biologics, 800 Research Parkway, Suite 200, Oklahoma City, OK, 73104, USA.
BioProcess Technology Group, BDO-USA Life Sciences Practice, 12 Gill St, Suite 5450, Woburn, MA, 01801, USA.
J Ind Microbiol Biotechnol. 2019 Oct;46(9-10):1297-1311. doi: 10.1007/s10295-019-02216-z. Epub 2019 Jul 17.
In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10-20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.
本工作概述了生物类似药市场、研发管线和行业目标。与创新药物的 12 年审批时间相比，生物类似药的审批时间通常更短（8 年），且开发成本可低至创新药物的 10-20%。本文还综述了生物类似药研发管线，以及为生成可追溯、可追踪数据集所需的质量管理体系（QMS）。与开发原创药物相比，开发生物类似药的一个不同之处在于，生物类似药需要更广泛的分析基础，并且讨论了在开发分析相似性以表征这些产品方面取得的进展。本文提供了一个实例，说明了在开发生物类似药时所探索的决策和考虑因素，包括基于成本、时间和效价确定最佳工艺参数和方法。最后讨论了生物类似药生产中需要考虑的因素以及实现生物类似药靶向开发所采用的方法。
