The Future of Biologics: Lessons from Hatch–Waxman

The article review the challenges and lack of robust biologics market competition and drug pricing impacts, the history of the small molecule generics marketplace and the subsequent early evolution of the biosimilar marketplace. The article then explores the potential of an abbreviated biologics license application pathway to market-akin to the market entry pathway for generics-as a policy lever for improving biologics drug price competition, drug affordability and expanded access.