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How does bioequivalence show that a generic drug works like an approved drug?

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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.

Bioequivalence is the standard used to ensure that a generic drug functions in the same way as its brand-name counterpart. It is defined as the property wherein two drugs with identical active ingredients possess similar bioavailability and produce the same effect at the site of physiological activity.1

By demonstrating bioequivalence, a manufacturer proves that the generic version is equivalent to the original brand-name agent regarding its intended use, its effects on the body, and its fate within the body. To meet these regulatory requirements, generic drugs must:2

Contain the same active ingredients as the brand-name version.2
Be of the same strength and use the same route of administration.2
Meet identical requirements for preparation.2
Maintain acceptable safety and efficacy profiles.2

Because generic manufacturers bypass the extensive costs of initial research, development, and clinical trials, these drugs are often more affordable for patients and health service providers while providing the same therapeutic benefits as the original medication.2

Are you interested in how patent expirations influence the availability of these affordable medications?