Bioequivalence of topical generic products. Part 1: Where are we now?

Abstract

Regulatory accepted methods for bioequivalence assessment of topical generic products generally involve long and expensive clinical endpoint studies. The only alternative relies on pharmacodynamic trials, solely applicable to corticosteroids. Considerable efforts have been channeled towards the development and validation of other analytical surrogates. The majority of these alternative methods rely on in vitro methodologies that allow a more sensitive and reproducible bioequivalence assessment, avoiding at the same time the financial burden that deeply characterizes clinical trials. The development and validation of these methods represent interesting areas of opportunities for generic drugs, since by enabling faster submission and approval processes, an enlargement of topical drug products with generic version is more easily attainable. This review aims to present a critical discussion of the most promising alternative methods, with particular emphasis on in vitro permeation studies and near infrared spectroscopy studies. Since the last technique is not broadly forecast as a bioequivalence assessment tool, its suitability is assessed by a careful analysis of patents that claim the use of NIR radiation in the skin. In fact, the extensive coverage of the devices that use this technology highlights its applicability towards a better understanding of the mechanism underlying topical drug delivery.

Keywords: Bioequivalence; IVPT; NIR; Patents; Regulatory science; Topical generic products.