Center for Biologics Evaluation Research Licensed Biological Products

This dataset contains a list of biological products regulated by the Center for Biologics Evaluation and Research (CBER). The Purple Book is the biological equivalent of the pharmaceutical Orange Book, and seeks to aid regulatory agents, generic manufacturers, and physicians by arming them with information related to biological products such as biosimilars including, for example, providing information regarding the interchangeability of products.

本数据集收录了由生物制品评估与研究中心（CBER）监管的生物制品清单。《紫皮书》作为药品橙书的生物等效版本，旨在通过为监管机构、仿制药生产商和医师提供有关生物制品（包括生物类似物等）的相关信息，以帮助他们掌握产品可互换性等方面的知识。