FDA Purple Book Database now includes all CBER-, CDER-licensed biological products

Regulatory NewsRegulatory News
| 03 August 2020 | By Kari Oakes 

The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database.
The current list of products maintained by the Center for Biologics Evaluation and Research (CBER) will not be further updated by FDA.
The agency explained that its initial Purple Book Database release in February 2020 “contained a limited data set that included all approved biosimilar products and their related reference products;” the database had both simple and advanced search functionality. In subsequent releases, FDA added in the information for all FDA-licensed biologic products, including those regulated by the Center for Drug Evaluation and Research (CDER).
The Purple Book Database now contains biosimilar and interchangeable biological products and allergenic, cell and gene therapy, hematologic, and vaccine products. Transition biologic products that were originally approved via New Drug Applications (NDAs) but transitioned to Biologic License Applications (BLAs) also appear in the database.
“The Purple Book Database is intended to improve transparency and functionality for stakeholders by providing a complete view of biological product options, including whether there are biosimilar and/or interchangeable product options, and to advance public awareness about FDA-licensed biological products, said FDA.


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Tags: FDA, US

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