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July 21 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.” The draft guidance would explain FDA's therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes, if finalized as written. FDA's therapeutic equivalence evaluations are listed for multisource prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book). These 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.

Submit either electronic or written comments on the draft guidance by September 19, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

FDA is announcing the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.” The draft guidance would explain FDA's therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes. Therapeutic equivalents are approved drug products that 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 prescription drug products approved under section 505 of the FD&C Act (21 U.S.C. 355) in the active section of the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the Orange Book). These 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 determining 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 without a sacrifice in the quality of treatment.

In the Federal Register of June 1, 2020 (85 FR 33165), FDA announced the establishment of a public docket to solicit comments on the Orange Book, including questions related to the presentation of information on therapeutic equivalence (e.g., “How useful is the second letter of a therapeutic equivalence evaluation code?”), which also relate to the content of this guidance. FDA is continuing to consider the comments to this docket.

Draft Guidance--Evaluation of Therapeutic Equivalence: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-therapeutic-equivalence
FRN: https://www.federalregister.gov/d/2022-15612

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