We sat down with Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), to discuss the true impact that suffixes have on biosimilar perception and whether they are appropriate for the United States.
The use of 4-letter suffixes for biologics has been a source of controversy in the United States since the FDA’s guidance on naming was released in 2015. The guidance stated that all newly approved biosimilars, interchangeable products, and originator biologics would add a 4-letter suffix to the end of the nonproprietary name, or molecule name, of the drug.
However, the FDA revised their guidelines in 2019, and many originator manufacturers were relieved to find that they would not have to add a suffix retrospectively to products already on the market. Although many argued that the suffixes cause confusion, some said suffixes add clarity distinguishing biologics from one another.
We sat down with Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA) to discuss the true impact that these suffixes have on biosimilar perception and whether the United States has the right idea about using them.
To learn more about biosimilar naming, click here.
Click here to learn more about the ACMA.