Bioequivalence

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Question

What is a bioequivalent drug?

Answer

A bioequivalent drug means that the generic medication's active ingredient works the same way in the body and in the same period of time as in its brand-name counterpart. (The active ingredient is the drug itself - the part of a medication that does what the product is designed to do.) Bioequivalence is one of many requirements of the Food and Drug Administration (FDA) before it will approve a new generic drug.

Also, when a generic drug is under development, its bioavailability is measured against that of the brand-name version. Bioavailability is the amount of the drug in the bloodstream and how long it took to get there.

Generic drug manufacturers must prove to the FDA that the generic drug undergoes the same-quality manufacturing standards as the brand-name counterpart and that it has similar labeling.

Learn more about common generic equivalent drugs.

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