Bioequivalence Assessment of Generic versus Reference Heparinoid-containing Moisturizer Based on Basal Sweating Capacity

Abstract

Because of government policy, the market share of generic topical products is rapidly growing in Japan, because biologic equivalence assessment in human is not required for approval of these generic products. We questioned whether generic topical products, especially moisturizers, are as effective as the reference products when used in humans with sweating capacity. We recently reported that the reference heparinoid-containing moisturizing cream (oil in water type) has a potent capacity to maintain skin surface hydration by persistently increasing basal sweating responses in humans, as compared with other moisturizers. In this study using impression mold technique, we examined whether the generic heparinoid products have effects on the basal sweating capacity similar to those of the reference products. We found that generic heparinoid-containing moisturizing cream did not significantly increase basal sweating responses or skin surface hydration at the application site, unlike the reference cream. For the bioequivalence assessment of generic topical moisturizers, the capacity of increasing basal sweating responses should be examined in addition to multiple bioequivalence tests in humans.