FDA Updates ‘Purple Book’ Database

After Recently Transitioning Biologics Lists To Online Data

The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.

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The FDA’s recently created online ‘Purple Book’ database gets an update • Source: Shutterstock

The “Purple Book” that keeps track of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations has been updated by the US Food and Drug Administration after recently becoming a searchable online database.

Overhauled in February 2020, the initial Purple Book database contained a limited data set that included all approved biosimilar products and their related reference products. Also see "FDA Overhauls...

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