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Evaluation of Therapeutic Equivalence | FDA Guidance for Industry

This guidance explains FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TEcodes).

As defined in 21 CFR 314.3(b), therapeutic equivalents are approved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

FDA’s therapeutic equivalence evaluations are listed for multisource approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations.

As FDA explained when it first proposed to make available a list of all approved drug products, together with therapeutic evaluations of listed products that are available from more than one manufacturer, therapeutic equivalence evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs.

For example, the Orange Book can assist in the establishment of formularies that States and other entities may use in determinin when drug products may be substituted for one another. If lower-cost, therapeutically equivalent drug products are available, American consumers are more likely to receive savings on these products.

Therapeutic equivalence evaluations are a scientific judgment based upon evidence, while generic substitution may involve social and economic policy administered by the states, e.g., reducing the cost of drugs to consumers.

These evaluations do not constitute determinations that any product is in violation of the FD&C Act or that any product is preferable to any other.

Resource Person: Barbara Pirola

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