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GUIDANCE DOCUMENT

Evaluation of Therapeutic Equivalence July 2022

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0528


Docket Number:
FDA-2022-D-0528
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate. The guidance explains how FDA evaluates drug products for, and determines TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). The guidance provides background on the fundamentals of TE and utilizes a question and answer format to provide more information on the therapeutic equivalence evaluation of approved drug products and assignment of TE codes in the Orange Book.

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