The U.S. Food and Drug Administration (FDA) recently approved the first follow-on biologic (commonly referred to as “biosimilars”) and will soon consider approving others. Given that many state laws allow for automatic substitution of biosimilars for biologics even though the two drugs are far from identical, congressional oversight is necessary to ensure that patient safety is the top priority of the FDA approval process and that individuals will not be at risk. The FDA is currently reviewing five biosimilar applications and is expected to accept more for review in the coming months. Yet, the FDA has not released final guidance on critical consumer safety issues, including the standard for interchangeability of biologics and biosimilars, the frequency of testing for specialized conditions, nomenclature for these new drugs, and labeling instructions. Read more about how groups are urging Congress to holding oversight hearings regarding the FDA biosimilar approval process here.
Last Updated on April 23, 2020 by Aimed Alliance
