ABSTRACT
A generic drug product, also referred to as a multisource pharmaceutical product, is considered to be ‘‘essentially similar’’ (1) or bioequivalent (2) to an innovator (brand name) product. Bioequivalence implies that a generic drug product is essentially identical to the brand name (reference) drug product in terms of active ingredient(s), strength, dosage form, route of administration, quality, safety, e⁄cacy, performance characteristics, and therapeutic indication. Generic drug products are typically sold at substantial discounts from their brand name counterparts.
