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How are generic drugs tested before they can be marketed?

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A lab technician wearing protective gloves and face shield lifts a rack of deep-frozen cells from a cryopreservation tank emitting vapor in a laboratory setting. — pharmaceutical industry A technician withdrawing deep-frozen cells for in vitro culture at a laboratory of a German pharmaceutical company.

Generic drugs are not required to undergo the same extensive clinical trials and research development as brand-name drugs because their safety and efficacy profiles have already been established by the original product. Instead, the primary regulatory requirement for marketing a generic version is to demonstrate bioequivalence to the original, already-approved brand-name drug.12

Bioequivalence means that the generic product must have the same rate and extent of absorption and produce the same blood concentration of the drug when administered in the same dose and dosage form. To ensure public safety, generic manufacturers must also meet the following standards:2

Active Ingredients: They must contain the same active ingredients as the brand-name version.1
Preparation: They must meet the same requirements for preparation, strength, and route of administration.1
Regulatory Oversight: They must adhere to government-mandated regulatory standards to ensure they are not adulterated or contaminated with toxic impurities, maintaining a favorable risk-to-benefit ratio for the public.3

By bypassing the redundant costs of initial clinical trials, generic companies can provide more affordable therapeutic options to patients and health service providers.12