Bioequivalence of drugs — Achieving comparable values for the extent and rate of release of the active pharmaceutical ingredient, the rate of absorption, the degree of arrival at the site of action and the rate of excretion when using drugs with the same active pharmaceutical ingredient, the same dose and a comparable dosage form.

Bioequivalence of drugs is a concept used in the pharmaceutical industry and in pharmaceutical legislation to compare two drugs (British English: medicinal products) containing the same active pharmaceutical ingredient in the same dose and dosage form and to determine how similar they are in terms of their bioavailability and therapeutic effect.

In plain language, bioequivalence (German translation: Bioäquivalenz) shows how similar one drug is to another in the way it affects a patient's body. This is particularly important for generic drugs, i.e. drugs that contain the same active pharmaceutical ingredients in the same dosage as the original drug, so that they can receive a marketing authorization more easily.

The assessment of bioequivalence includes clinical trials on healthy volunteers or patients. These studies usually analyze the time it takes for the active pharmaceutical ingredient to enter the blood (time to onset of action) and the rate at which the active pharmaceutical ingredient is excreted from the body (half-life). By measuring the plasma levels (German: Plasmaspiegel) of the active pharmaceutical ingredient at different points in time, a plasma level curve is obtained from which the various parameters can be extracted. If the parameters for the time to onset of action, the duration and intensity of the effect of the drug and its blood levels are within the prescribed limits, the drugs are considered bioequivalent.

For market authorization purposes, bioequivalence comparisons are important to ensure that generic versions of drugs have the same therapeutic efficacy and safety as the brand-name drugs. Bioequivalence assessments help to ensure the availability of generic drugs (translation into German: Generika), which are generally less expensive, but still effective and safe.

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