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The Future of Biologics: Lessons from Hatch-Waxman.
Brian J Miller1,2, Janet Woodcock3
1Division of Hospital Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA. brian@brianjmillermd.com.
Therapeutic Innovation & Regulatory Science
|April 7, 2026
Summary
This review examines biologics market competition and drug pricing challenges. It explores an abbreviated biologics license pathway to enhance competition and affordability.
Area of Science:
- Health Economics
- Pharmaceutical Policy
- Biotechnology
Background:
- The biologics market faces challenges in competition and drug pricing.
- The small molecule generics market has a history of competition, influencing biosimilar evolution.
- Early evolution of the biosimilar marketplace presents opportunities for policy intervention.
Purpose of the Study:
- To review challenges in biologics market competition and drug pricing.
- To explore the potential of an abbreviated biologics license application pathway.
- To assess policy levers for improving biologics price competition, affordability, and access.
Main Methods:
- Literature review of biologics market competition.
- Historical analysis of small molecule generics and biosimilar marketplaces.
- Policy analysis of abbreviated biologics license application pathways.
Main Results:
- Lack of robust competition impacts biologics pricing.
- The generics pathway provides a model for biosimilar market entry.
- An abbreviated pathway could improve price competition and access.
Conclusions:
- Policy interventions, such as abbreviated pathways, are crucial for fostering biologics market competition.
- Enhanced competition can lead to lower drug prices and improved patient access.
- Further exploration of regulatory pathways is needed to optimize the biosimilar market.
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