Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US

There is little evidence to support biologics having longer periods of market exclusivity or protection from negotiation. As a result of differential treatment, US law appears to overly reward the development of biologics relative to small-molecule drugs.

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Publication Details

Journal
JAMA
Published
2024-11-25
DOI
https://doi.org/10.1001/jama.2024.16911
Citations
17
Primary Topic
Pharmaceutical Economics and Policy
Type
article
Field-Weighted Citation Impact
19.20

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article

Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US

Matthew Vogel, S. Sean Tu, William B. Feldman, Aaron Seth Kesselheim et al.
17 citations
JAMA
Pharmaceutical Economics and Policy
19.20
article

Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US

Matthew Vogel, S. Sean Tu, William B. Feldman, Aaron Seth Kesselheim, Olivier J. Wouters, Reed F. Beall
article en
17 citations

Abstract

There is little evidence to support biologics having longer periods of market exclusivity or protection from negotiation. As a result of differential treatment, US law appears to overly reward the development of biologics relative to small-molecule drugs.

JAMAVol. 332(24)
West Virginia University (US), Brigham and Women's Hospital (US), Harvard University (US), University of Calgary (CA), John F. Kennedy University (US), London School of Economics and Political Science (GB)
Arnold Ventures
Partnerships for the goals
Openalex Percentile: Top 1%
Pharmaceutical Economics and Policy
19.20
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Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US — Matthew Vogel, S. Sean Tu, et al. · JAMA (2024) | TGRS Research Map | TGRS