Fact Sheet

Biosimilars Labeling

PhRMA April 8, 2016

U.S. Food and Drug Administration (FDA)-approved prescription drug labeling is the most authoritative mechanism for communicating information about a medicine’s safety and effectiveness to health care providers. The approved labeling summarizes key scientific information about a medicine that health care providers need to assess its benefit-risk profile and determine if the medicine is appropriate for use in treating a particular patient.