FDA Draft Guidance for Industry, Evaluation of Therapeutic Equivalence

July 20, 2022

FDA Draft Guidance

July, 2022

As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry, Evaluation of Therapeutic Equivalence. This draft guidance explains FDA’s therapeutic equivalence (TE) evaluations, including the assignment of TE codes. Therapeutic equivalents are approved drug products that FDA has determined are pharmaceutical equivalents for which bioequivalence has been demonstrated, and 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 TE evaluations are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). These TE 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 determining when drug products may be substituted for one another. If lower-cost, therapeutically equivalent drug products are available, American consumers have more treatment options with the same safety, efficacy, and quality.

The draft guidance includes information on:

  • The fundamentals of TE
  • Products eligible for TE evaluation
  • The TE coding system
  • Revisions to TE evaluations

The agency is publishing this draft guidance as part of the Drug Competition Action Plan, which aims to facilitate more generic competition, promote patient access, and ultimately improve health care costs.

Download Draft Guidance

Read the Federal Register Notice

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