2024
DOI: 10.1001/jama.2024.16911
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Differential Legal Protections for Biologics vs Small-Molecule Drugs in the US

Olivier J. Wouters,
Matthew Vogel,
William B. Feldman
et al.

Abstract: ImportanceBiologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resource… Show more

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