FDA’s Regulatory Reforms to Unlock Competition and Lower Drug Costs

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Authors: Martin A. Makary, Sarah Yim, Mustafa Ünlü, M. Stacey Ricci
Cited by: 3
References: 1

Abstract

This Viewpoint from the FDA explains efforts to remove burdensome criteria for biosimilar approvals and encourage use of biosimilars over branded biologics, which could lead to greater access to biosimilars for patients and reduce treatment costs.

Fields of Study & Subjects

Biosimilars and Bioanalytical Methods Pharmaceutical Economics and Policy Biomedical Ethics and Regulation

Publication details

Journal / source
JAMA
Publisher
American Medical Association (AMA)
Volume
335
Issue
17
Pages
1473–1473
Publication date
9 March 2026
Language
EN