The Future of Biologics: Lessons from Hatch–Waxman

Key Points

• The aim is to analyze the competition issues in the biologics market and propose solutions for drug affordability.
• Reviewed historical challenges in the small molecule generics market.
• Examined the early evolution of the biosimilar market.
• Explored policy implications of an abbreviated biologics license application pathway.
• Identified significant barriers to biologics market competition.
• Outlined potential benefits of adopting a generics-like approval pathway for biosimilars.
• Suggested that improving market strategies could enhance drug affordability and access.

Abstract