FDA project: Bioequivalence of topical generics

Generic drugs are an attractive alternative to reference listed drugs, because they have the same treatment effect but are generally available at considerably lower costs. To be approved, a generic drug must show the same therapeutic effect as the reference listed drug (bioequivalence). However, methods that can show bioequivalence for dermal drugs directly in the skin are missing, which explains the limited number of generic drugs available for skin diseases.

In this project, the successful application of OFM to determine the bioequivalence and non-bioequivalence of hydrophilic topical creams was demonstrated for the first time and we were able to answer the following questions:

• Did the drug enter the skin?
• How much of the drug entered the skin?
• How long did the drug stay within the skin?

The succesful determination of bioequivalence of generic drugs in the skin and the answers to these questions by using OFM helps to accelerate the further development of generic medications in the skin.

We are currently working on the second follow-up project with the US FDA, in which the development of dOFM as a standardized method to determine bioequivalence of topical drugs in the skin is being driven forward.

Bodenlenz M, Tiffner KI, Raml R, Augustin T, Dragatin C, Birngruber T, et al. Open Flow Microperfusion as a Dermal Pharmacokinetic Approach to Evaluate Topical Bioequivalence. Clin Pharmacokinet 2017;56:91–8. doi:10.1007/s40262-016-0442-z.​​​​​​​