FDA’s Regulatory Reforms to Unlock Competition and Lower Drug Costs
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.
Authors
- Martin A. Makary (ORCID: https://orcid.org/0000-0001-6091-4929)
- Sarah Yim
- M. Stacey Ricci
- Mustafa Ünlü
Institutions
- United States Food and Drug Administration (US)
Publication Details
- Journal
- JAMA
- Published
- 2026-03-09
- DOI
- https://doi.org/10.1001/jama.2026.3088
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.00