FDA Explains Therapeutic Equivalence Evaluations in Draft Guidance

In a new draft guidance, the FDA outlined its approach to evaluating therapeutic equivalence and the assignment of codes for use in the agency’s Orange Book — which lists approved drug products with therapeutic equivalence evaluations.

To qualify for therapeutic equivalence, a drug product must show pharmaceutical equivalence, bioequivalence and the same clinical effect and safety profile for the conditions of use specified in the labeling as the reference product, the agency said.

To determine pharmaceutical equivalence, the product needs to be identical in dosage form and route or routes of administration, contain identical amounts of the identical active drug ingredient and meet the identical compendial or other applicable standard of identity, strength, quality and purity, including potency and, where applicable, content uniformity, disintegration times and/or dissolution rates.

However, the inactive ingredients do not need to be identical, the agency said.

The FDA said it scrutinizes the labeling when determining the clinical effect and safety profile. If there are labeling differences, a drug product would not be considered therapeutically equivalent, the agency said.

The deadline for comment on the draft is Sept. 19.

Read the draft guidance here: bit.ly/3OpEctK.