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The Future of Biologics: Lessons from Hatch-Waxman.

PubMed
Authors: Miller BJ, Woodcock J

Year

2026

Paper ID

56340

Status

Peer-reviewed

Abstract Read

~2 min

Abstract Words

69

Citations

0

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.

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  • This paper contributes to the Quantum Software Tools & Programming research area in the Quantum Articles archive.
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  • 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...

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