The future of non-human primates in the development of biopharmaceuticals

Abstract

Due to the characteristics unique to monoclonal antibodies (MAbs) and other biotech products, non-human primates (NHP) are often assumed to be the only relevant species to evaluate safety and efficacy of MAbs. However, the scientific value of NHP in MAb development has never been adequately established, and has been debated since it became clear that the nonclinical safety programmes used for small molecule therapeutics would not be appropriate for MAbs. In this retrospective analysis, we studied the value of using NHP to evaluate the safety and efficacy of these products. To do this, we had unique access to the drug registration files of all MAbs marketed in the European Union. Inadequately justifying the use of NHP as a primary non-clinical species and the use of study designs that were considered ineffective led to a needless increase of NHP use. The value of NHP in non-clinical assessment was further limited by immunogenicity. But more importantly, NHP do not stand out as a predictive model because MAbs primarily exert their expected pharmacological effect. Nevertheless, their use continues to increase. There is an urgent need for a reevaluation of the need for routine studies with NHP to develop MAbs.