Differences among Pharmaceutical Equivalent, Therapeutic Equivalent, Bioequivalent and Pharmaceutical Alternative
Pharmaceutical Equivalents (PE)
- Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, have the same route of administration, and are identical in strength or concentration.
- Pharmaceutical equivalent products need to meet the same or compendial or other comparable standards (strength, quality, purity, and identity).
- Pharmaceutical equivalent products may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients, expiration time, and, within certain limits, labeling.
- Pharmaceutical equivalent products do not necessarily imply bioequivalence as differences in the excipients and/or the manufacturing process can lead to faster or slower dissolution and/or absorption.
Therapeutic Equivalents (TE)
- Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
- Therapeutic equivalents can be demonstrated by appropriate equivalence studies, such as pharmacokinetic, pharmacodynamic, clinical, and/or in vitro studies.
Bioequivalent (BE)
- Two medicinal products are considered to be Bioequivalent if the pharmaceutical equivalent or pharmaceutical alternative products that display comparable BA when studied under similar experimental conditions.
- In terms of rate Cmax and tmax and the extent of absorption (area under the curve [AUC]) are similar to such a degree that their effects can be expected to be essentially the same.
Pharmaceutical alternatives (PA)
- Drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety but are different salts, esters, or complexes of that moiety or are different dosage forms or strengths.
- They may or may not be bioequivalent or TE to the comparator product.
