title: What makes a generic medication generic?
abstract: By law, the U.S. Food and Drug Administration (FDA) can approve generic versions of brand-name drugs without requiring that research be conducted to prove them safe and effective. However, compared with a brand-name drug, a generic drug must demonstrate that it (a) contains the same active ingredients; (b) is identical in strength, dosage form, and route of administration; (c) is bioequivalent; (d) has the same clinical use indications; (e) meets the same batch requirements for identity, strength, purity, and quality; and (f) is manufactured according to the same FDA regulations. The most important aspect of generic drug development are the concepts of bioavailability and bioequivalence. According to the concept of bioequivalence, if a drug product contains an active ingredient that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is considered to be clinically equivalent and can be substituted for that drug product.
authors.affiliation: University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA 15213, USA. HowlandRH@upmc.edu
authors.forename: Robert H
authors.initials: RH
authors.lastname: Howland
mesh_terms: D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval / Q000458:organization & administration*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D016568:Drugs, Generic / Q000737:chemistry / Q000493:pharmacokinetics / Q000627:therapeutic use; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration
chemical_list: D016568:Drugs, Generic