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.

Corresponding Author: Martin A. Makary, MD, MPH, US Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993 (commissionersoffice@fda.hhs.gov).

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