Abstract

The rise of bio- and nano-technologies has accelerated the development of complex drug products, a class of products that includea€”but are not limited toa€”Non Biological Complex Drugs (NBCDs). NBCDs (e.g., glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions, and liposomes) consist of different (closely related and often nanoparticulate) structures that cannot be fully quantitated and characterized by physico-chemical analytical means. The complex nature of NBCDs means that minute variations in the manufacturing process can substantially change the composition of final products, and this poses a challenge for the development of regulatory guidelines. While guidance for developing generic versions of small molecule drugs is well-established, and progress has been made for biologic complex drugs, there is very little guidance for follow-on versions of NBCDs. This is further complicated by the difficulty of aligning strategies of international regulatory bodies due to their different legal frameworks. To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry, and drug manufacturing.