Which factors determine therapeutic equivalence?

The determination of therapeutic equivalence hinges primarily on the safety, efficacy, and bioequivalence of a medication. Therapeutic equivalence means that two drugs are expected to have the same therapeutic effect and safety profile when administered to patients under the conditions specified in their labels.

Safety refers to the absence of harmful effects when the medication is used as directed. Efficacy denotes the ability of the drug to produce the intended therapeutic outcome. Bioequivalence assesses whether two different formulations of the same drug release their active ingredient into the bloodstream at a similar speed and to a similar extent, which is crucial for ensuring that patients receive consistent therapeutic outcomes. If two formulations meet these criteria, they can be considered therapeutically equivalent.

Other factors listed, such as the dosage form, route of administration, cost, manufacturer reputation, and FDA approval status, may play roles in medication choices and patient access but do not specifically determine therapeutic equivalence. Therapeutic equivalence focuses tightly on how the drugs perform clinically rather than administrative or economic factors.