FDA Releases Much-Anticipated Guidelines on Biosimilar Naming


This week, the U.S. Food and Drug Administration (FDA) released its much-anticipated guidelines on the naming of approved biosimilars. The guidelines propose that the original biologic drug (i.e., reference product) and its biosimilar counterpart share a common drug name, and both would be followed by a unique series of four letters to help distinguish between the two different drugs. To date, only one biosimilar has been approved. The FDA is also seeking input for naming guidelines for previously-approved biologic products. Aimed Alliance supports a naming convention that clearly distinguishes biologics from biosimilars in order to preserve patient health and safety. To learn more on the new FDA biosimilar guidelines, click here. To read the Reuters article, click here.


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