Definition, categorization, and environmental risk assessment of biopharmaceuticals

Abstract

Biopharmaceuticals are associated with the revolutionary treatment of various diseases, and according to the European Medicines Agency, biopharmaceuticals derived from biological sources are perceived to not cause significant environmental risk. However, there is currently no broadly recognized definition or categorization of biopharmaceuticals despite the fact that improved technology has made it possible to modify them to obtain more efficient medicines, thereby raising questions about their biological origins and risks. The aim of this paper, based on a literature review, is to derive a clear definition of biopharmaceuticals and evaluate the European Union's regulation and environmental risk assessment (ERA) procedures for them. Nine different definitions were identified, and it is evident that the term "biopharmaceuticals" is used ambiguously. We therefore recommend that biopharmaceuticals are defined as complex molecules derived from a biological source, with the purpose to diagnose, prevent, treat, or cure diseases or conditions of human beings. Furthermore, we recommend that biopharmaceuticals should be categorized according to their biological structure: 1) amino acids, 2) nucleic acids, and 3) vaccines. Only 11 studies were identified as being relevant to ERA, and we lack useful data for hazard identification. More research is needed to examine the ecotoxicity, fate, and stability of most biopharmaceuticals-and categorical regulatory exclusion seems unfavorable in this regard.

Keywords: Biopharmaceuticals; Categorization; Definition; Environmental risk assessment; European medicines agency; Review.