Evergreening biologics

Abstract

This article discusses the exclusivity provisions of the Biologics Price Competition and Innovation Act of 2009 (the ‘Biologics Act’), as well as Congressional intent to avoid ‘evergreening’ of biologic drug products. Concludes that the FDA should deny any ‘new’ period of exclusivity when an application relating to a structurally modified reference product does not demonstrate, through ‘full clinical safety and efficacy data’ that differences in ‘safety, purity, or potency’ exist in a ‘second generation’ product that are both ‘clinically meaningful’ and patient favorable.