Drugs

Guidance on Adhesion Testing for Generic Transdermal/Topical Drugs

FDA has finalized a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical delivery systems, providing updated recommendations intended to standardize studies supporting ANDAs for products such as patches and extended-release films.

FDA says consistent adhesion is a critical quality attribute because the amount of drug delivered depends on how much of the delivery system remains attached to the skin throughout the labeled wear period. Poor adhesion can reduce drug absorption, complicate bioequivalence assessments, and increase the risk that a detached patch could expose children or other unintended individuals to the medication, it says. The agency recommends comparative adhesion studies using randomized crossover designs in which generic and reference products are evaluated under real-world conditions, including normal daily activities and routine showering when consistent with product labeling.

Among the updates in the final guidance, FDA clarified appropriate methods for estimating the percentage of a product's surface area that remains adhered to the skin and refined its recommendations for statistical analysis. The agency continues to recommend a five-point adhesion scoring scale for primary comparative analyses but encourages developers to explore alternative scoring methods after discussing with FDA during pre-ANDA meetings. The guidance also states that photographs collected during adhesion assessments are intended to support visual observations rather than automated or photometric analyses.

For statistical evaluation, FDA recommends using the mean adhesion score as the primary endpoint and demonstrating that the generic product is noninferior to the reference listed drug using a noninferiority margin of 0.15 on the recommended five-point scale. The guidance also encourages sponsors to conduct additional descriptive analyses, including rates of significant detachment and time to loss of adhesion, and notes that adhesion and pharmacokinetic bioequivalence may be evaluated in a single study if adequately powered for both objectives.

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