The Purple Book: Evaluations, Approvals and recent updates
Abstract
The Purple Book is an informative database of all FDA-licensed biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products. and allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER). The current article emphasizes the significance of the Purple Book and the new law, The Purple Book Continuing Act enacted about approved patented biologic products, marketing status etc. The Act codifies a number of FDA's current Purple Book practices, and imposes a new requirement for publishing the reference product sponsor's "patent lists" exchanged in the so-called "patent dance" of BPCIA biosimilar litigation. Biologics approved for 2020-21 are listed.
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References
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-demonstrating-interchangeability-reference-product-guidance-industry
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