Coping with the Regulatory Realities of Follow-on Biologics and the Nuances of US and European Regulations

Abstract

It is well recognized that biopharmaceuticals provide great value in treating a number of chronic diseases but that the costs of these therapies have often been prohibitive. As patents and market exclusivity expire on a number of innovator products, there is an opportunity to develop follow-on versions of these products that have the potential to reduce health care costs worldwide. Presented here is a history of regulation, examples of approved molecules, terminology, and the current state of regulatory approaches open to follow-on biologics seeking market approval in the United States. Additionally, the regulations established by the European Union and the pending US legislation are reviewed. It is thought that new legislation will be available in the near future for the development of follow-on biologics that will facilitate improved competition in the US biopharmaceutical market.