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.

中文翻译：

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目前对生物仿制药的看法。

在这项工作中，将讨论生物仿制药市场，管道和行业目标的概述。生物仿制药的批准时间通常较短（8年），而创新药物为12年，开发成本可能是创新药物的10-20％。审查了生物仿制药管道以及生成可追溯的可追踪数据集所需的质量管理系统（QMS）。与原研药相比，开发生物仿制药之间的一个区别是生物仿制药需要更广泛的分析基础，并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。提出了一个有关生物仿制药开发过程中决策和考虑因素的示例，其中包括根据成本，时间和效价确定最佳工艺参数和方法。