Generic Biopharmaceuticals: Towards a Science-Based Abbreviated Process

This paper provides an overview of key regulatory and technical issues related to the approval of biotechnology products in the USA by an abbreviated pathway. Technological advances now permit accurate analytical comparisons of innovative and generic biotechnology products. These sophisticated analytical techniques, along with pharmacodynamic, pharmacokinetic and limited clinical testing, provide an array of comparative tools to demonstrate the equivalence of innovative and generic products. Using a case by case evaluation, there are currently biotechnology products that could be approved based on abbreviated data packages.