What is Therapeutic Equivalence?

Therapeutic Equivalence

According to the FDA, when two drugs have the same clinical effect and are nearly identical in treating a disease or injury.

Bioequivalent

Equal in effectiveness and safety, and equally absorbed when taken into the body.

Active Ingredient

The substance in a drug that makes it do what it is designed to do.

Requirement 1 for Equivalence

Drugs must be bioequivalent.

Requirement 2 for Equivalence

Both drugs must contain identical amounts of the same active ingredient.

Requirement 3 for Equivalence

Both drugs must have the same strength, dosage form, and route of administration.

Requirement 4 for Equivalence

Both drugs must meet the same applicable standards regarding quality and purity.

Route of Administration Example

Why Drug A (taken by mouth) and Drug B (taken as an eye drop) cannot be therapeutic equivalents.

Appearance (Size, Color, Shape)

A feature that therapeutic equivalent drugs do NOT need to have in common.

Scoring

A groove in a tablet indicating where it may be divided; not required to be identical in equivalents.

Flavoring or Additives

Inactive components that therapeutic equivalent drugs do not need to share.

Packaging

An external feature that does not need to be identical for two drugs to be therapeutic equivalents.

Preservatives

An inactive added substance used to extend drug life or prevent microorganism growth; not required to match.

FDA Agency Role

The US government organization that defines and regulates therapeutic equivalence.

Manufacturer Difference

Therapeutic equivalents can come from different manufacturers.

Absorption Property

Part of bioequivalence meaning drugs are equally absorbed in the body.

Safety Property

Part of bioequivalence meaning drugs are equally safe to use.

Effectiveness Property

Part of bioequivalence meaning drugs are equally effective.

Quality Standards

Regulations regarding manufacturing excellence that equivalents must equally meet.

Purity Standards

Regulations ensuring drugs are free of contamination that equivalents must equally meet.