FDA regulatory

Reference product

Definition

The originally licensed biological product against which a biosimilar is compared.

The reference product holds the exclusivity period that determines when biosimilars can enter.

BiosimilarA biological product highly similar to an already-licensed reference product, with no clinically meaningful differences.Definition Purple BookThe FDA database of licensed biological products, including biosimilars and interchangeables.Definition

More in FDA regulatory

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

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