Table 3.

FDA Approval Pathways for Chemical Drugs, Generics, Biologics, and Biosimilars.

	Chemical drugs	Generics	Biologics	Biosimilars
Application	New drug application (NDA)	Abbreviated NDA (ANDA)	Biologics License Application (BLA)	Abbreviated application
Pathway	505 (b)	505 (j)	351 (a)	351 (k)
Law	Federal Food, Drug, and Cosmetic Act	Hatch-Waxman Amendment 1984	Public Health Service Act	BCPI Act
Evidence	Full safety and effectiveness data*	Bioequivalence and Pharmacokinetic (PK) studies	Full safety and effectiveness* and purity	Full safety and effectiveness*, analytical data, comparative studies to demonstrate safety, efficacy, and purity
Designation	Reference Standard (RS) “Patent” Exclusive marketing	Therapeutic Equivalent to RLS. Many generics can be produced for an original product	Original or Reference listed drug which is “Patent” for 10–15 years with exclusive marketing	Interchangeability to be determined. Many biosimilars can be produced for a reference product
Indexed	FDA approval list	Orange book †	Purple book ‡	Purple book

^*Full safety and effectiveness data include preclinical, pharmacokinetics /pharmacodynamics, and human clinical studies.

^†Orange book includes approved drug products with therapeutic equivalence evaluations by FDA.

^‡Purple book includes lists of licensed biological products with reference product exclusivity and bio-similarity or interchangeability evaluations.