07/26/2022
Photo by Christina Victoria Craft on Unsplash
The US Food and Drug Administration (FDA) released a draft guidance “Evaluation of Therapeutic Equivalence” July 2022 on how it evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes. Therapeutic equivalence means that drugs are 1) pharmaceutically equivalent, 2) bioequivalent, and 3) have the same clinical effect and safety profile. If drugs are evaluated as therapeutical equivalence, they may be substituted for each other. The FDA reviews the drug labeling as part of the determination. Only certain drugs approved under Section 505 of the FD&C Act are evaluated for TE. Section 505 includes stand alone new drug applications (NDA), 505(b)(2) applications, and abbreviated new drug applications (ANDA). Since stand alone NDAs usually are not pharmaceutically equivalent, they are not generally evaluated for TE. 505(b)(2) application drugs are not routinely evaluated for TE, but it can be requested by petition. Generic drugs approved under ANDA would be evaluated for TE.
Another part of the draft guidance describes the Therapeutic Equivalence Coding System in the Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”). Codes are assigned to multi-source drugs and list if the approved drug has been determined to be therapeutically equivalent to another approved drug. For example, a code starting with an ‘A’ is a drug that is evaluated to be TE. New information may lead to adjustments in the therapeutic equivalence evaluations, which would be reflected with a code change in the Orange Book.
The draft guidance also contains fourteen frequently asked questions with answers. When the draft guidance is finalized, it will help clarify how the FDA evaluates and codes therapeutic equivalence of drugs.
Comment now through September 19, 2022 HERE.
- The Clinical Pathways Team
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