Work

The Future of Biologics: Lessons from Hatch–Waxman

Year: 2026

Type: article

Abstract: 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.

Source: Therapeutic Innovation & Regulatory Science

DOI: 10.1007/s43441-026-00961-9

Authors: Brian J. Miller, Janet Woodcock

Institutions: Hoover Institution, Johns Hopkins University, Johns Hopkins Medicine

Language: English

Topic: Pharmaceutical Economics and Policy

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

Open Access status: hybrid

Estimated APC paid: $4,090

OpenAlex ID: W7151328566