Whitepaper – Evaluation of Therapeutic Equivalence Guidance for Industry

“The Food and Drug Administration (FDA or Agency) recently (June 2020) announced the availability of a draft guidance for industry entitled “Evaluation of Therapeutic Equivalence.” The draft guidance explains the FDA’s proposed approach to therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes, if finalized as written. Historically, draft guidance’s from FDA have been close the final guidance. 

The FDA’s therapeutic equivalence evaluations help state health agencies, prescribers, and pharmacists decide which drug products may be substituted for one another. These evaluations are based on scientific evidence and do not constitute determinations that any product is preferable to any other. Understanding these considerations can be invaluable to organizations contemplating development and manufacturing of applicable new therapies.”