FDA regulatory

Purple Book

Definition

The FDA database of licensed biological products, including biosimilars and interchangeables.

The biologics counterpart to the Orange Book, recording reference products and their exclusivity periods.

BiosimilarA biological product highly similar to an already-licensed reference product, with no clinically meaningful differences.Definition Interchangeable biosimilarA biosimilar that meets an additional standard permitting pharmacy-level substitution without prescriber involvement.Definition Biologics License Application (BLA)The application for a biological product — a monoclonal antibody, vaccine, cell or gene therapy.Definition

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505(b)(2)AB rating Abbreviated New Drug Application (ANDA)Active ingredient Active moiety Boxed warning Chemical structure (CS)Dosage form

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