FDA Draft Guidance On Evaluation Of Therapeutic Equivalence

• Published date: 05 August 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law
• Law Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
• Author: Mr Marcelo Barros

On July 21, 2022, the FDA issued draft guidance titled "Evaluation of Therapeutic Equivalence." In this guidance, the FDA explains therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes ("TE" codes). The FDA's therapeutic equivalence evaluations are listed for certain drug products approved under section 505 of the FD&C Act in the Orange Book and serve as public information and advice to state health agencies, prescribers, and pharmacists.

The first part of the guidance explains the criteria the FDA uses to assess whether a drug product can be deemed therapeutically equivalent to a previously approved drug product. The guidance explains that for a prescription drug product to be considered "therapeutically equivalent" to another product, the drug product must be:

(1) pharmaceutically equivalent,

(2) bioequivalent, and

(3) have the same clinical effect and safety profile for the conditions of use specified in the labeling.

Pharmaceutical equivalence is shown when two products share: (i) identical dosage form and route(s) of administration, (ii) identical amounts of the identical active drug ingredient to be delivered over an identical dosing period, and (iii) meet identical standards for identity, strength, quality, and purity, including potency. In short, the active drug ingredient in the two products are pharmaceutically (i.e. chemically) indistinguishable, though they may have different inactive ingredients.

Bioequivalence relates to the availability of the drug to the body. A drug product is deemed bioequivalent to another when there is no "significant difference in the rate and extent to which the active ingredient or active moiety . . . becomes available at the site of the drug action when administered at the same molar dose under similar conditions in an appropriately designed study." The FDA has issued regulations and other guidance concerning how to demonstrate bioequivalence.

Finally, to determine if a product has the same clinical effects and safety profile for a given use identified in the labeling, the FDA looks carefully at what is specified in the labeling. This inquiry is a product-specific determination and may result in two pharmaceutically equivalent products not being considered therapeutically equivalent if there are labeling differences.

The second part of the draft guidance explains that the FDA only evaluates certain drug products approved under section 505 of the FD&C Act for...