Drugs

FDA Issues New Guidance on Therapeutic Equivalence Evaluations

FDA has issued a final guidance describing how it evaluates therapeutic equivalence among prescription drug products and assigns therapeutic equivalence codes in the agency’s Approved Drug Products With Therapeutic Equivalence Evaluations (aka, the Orange Book).

The document, “Evaluation of Therapeutic Equivalence,” describes the scientific and regulatory principles the agency uses to determine whether drug products can be substituted with the expectation that they will produce the same clinical effect and safety profile.

The agency says therapeutic equivalence rests on three elements: pharmaceutical equivalence, bioequivalence, and an expectation of the same clinical effect and safety profile under the conditions specified in labeling. To be pharmaceutically equivalent, products generally must have identical dosage forms and routes of administration, contain identical amounts of the same active drug ingredient, and meet the same applicable standards for identity, strength, quality and purity, it says. They do not necessarily have to contain the same inactive ingredients.

FDA says products must also be bioequivalent, adding that the guidance describes bioequivalence as the absence of a significant difference in the rate and extent to which an active ingredient or active moiety becomes available at the site of drug action when products are administered at the same molar dose under similar conditions in an appropriately designed study.

Finally, FDA evaluates whether products can be expected to have the same clinical effect and safety profile when used according to their labeling. The agency says this determination can be product-specific, including for generic drug-device combination products whose user interfaces may differ from those of their reference listed drugs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome