On March 7, 2019, FDA issued draft guidance that describes FDA’s current thinking on nonproprietary names of biological products licensed under section 351 of the Public Health Service Act (PHS Act) that do not include an FDA-designated suffix.
FDA recognizes that licensure of new biological products, including biosimilar and interchangeable products, will continue to grow in the next few years. To reduce confusion and ensure patient safety, FDA promulgated a naming convention in January 2017 for nonproprietary naming of biological products. The 2017 convention included a core name that is designated by the United States Adopted Names Council and is shared between the reference product any biosimilar products, along with a four-letter suffix that would be a unique identifier for each product. The 2017 convention applied retroactively to biological products licensed before the naming convention, but did not apply to interchangeable products because the FDA was still preparing a separate naming convention for interchangeables. Further information about the 2017 convention can be found here.
The draft guidance proposes to remove transition biological products from the scope of the 2017 convention. Additionally, the draft guidance deletes the retroactive effect of the 2017 convention, directing FDA to not modify the names of biological products that were already licensed without a unique suffix. The draft guidance says that removing the retroactive application of the 2017 convention minimizes the burden of product sponsors to rename their products and reduces the opportunity for confusion for healthcare providers and patients that changing a product name might cause. The 2017 convention would still apply to any newly licensed biological products.
Also, the draft guidance proposes a naming convention for interchangeable products that mirrors the 2017 naming convention. Rather than sharing both the same core name and four-letter suffix as the reference product, interchangeable products will instead have a unique four-letter suffix. The distinguishing suffix allows healthcare providers and patients to know exactly which biological product is dispensed and reduces potential name-change confusion if a product is first licensed as a biosimilar and later licensed as an interchangeable product. Instead, the biological product would have the same name if licensed as a biosimilar and then subsequently as an interchangeable product.
FDA also briefly mentioned that vaccines are currently within the scope of the 2017 convention, but FDA is currently evaluating whether the naming convention is required to ensure patient safety given the current identification systems associated with vaccines.