Therapeutic equivalence (TE)
What is therapeutic equivalence (TE)?
Therapeutic equivalence is applied when a drug has the same active ingredient, dosage/concentration/strength, delivery route, and form/identity (e.g., capsule, tablet, liquid) as a brand-name drug. Therapeutically equivalent drugs must be bioequivalent with their brand-name counterpart, which means they must be processed and metabolized by the body in the same way. However, while all TE drugs must be bioequivalent, not all bioequivalent drugs are TE.
TE drugs can be identified through the therapeutic equivalence code developed by the Food and Drug Administration (FDA) for cataloging in their Orange Book. All approved drugs are included in the Orange Book, and those that are TE have a code starting with the letter “A.”
How do TE drugs improve healthcare?
By having the same therapeutic effect as a brand-name drug, TE drugs offer the same health outcomes for patients but at a fraction of the price. Generic medications are often a less costly alternative, and having TE means that patients do not have to sacrifice outcomes for cost.
Furthermore, if a drug is determined to be TE, it can go through a shorter, more cost-effective approval process, which allows manufacturers to bring their products to market quicker.