FDA Releases Final Guidance on Naming of Biological Products
January 19, 2017
The Food and Drug Administration (FDA) has issued a final guidance for industry on the nonproprietary naming of biological products.
Under the naming convention outlined in the guidance, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name with two parts:
- A core name that will be the same for all products.
- A distinguishing suffix that is devoid of meaning and composed of four lowercase letters, separated from the core name by a hyphen.
The FDA expects that the distinguishing suffixes will be used routinely when identifying, describing, and recording use of biological products.
The FDA intends to apply the naming convention retrospectively to all previously approved products as well as prospectively to newly licensed products. Current license holders (i.e., companies with approved products) and applicants (i.e., companies seeking to have a new biological product licensed) are invited to submit up to 10 proposed suffixes for consideration by the FDA. The guidance specifies that at least three of the four lowercase letters in the suffix must be distinct. The suffix also must be unique, nonproprietary, and free of legal barriers that would restrict its usage. The proposed suffix should not:
- Be false or misleading, such as by making misrepresentations with respect to safety or efficacy.
- Include numerals and other symbols aside from the hyphen attaching the suffix to the core name.
- Include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order.
- Contain or suggest any drug substance name or core name.
- Look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting).
- Look similar to or otherwise connote the name of the license holder.
- Be too similar to any other FDA-designated nonproprietary name suffix.
These requirements will necessitate changes in the names of several approved products. For example, filgrastim (Neupogen; Amgen) will get a suffix—likely filgrastim-jcwp, which was included in a proposed rule on the designation of official names and proper names for certain biological products. Filgrastim-sndz (Zarxio; Sandoz) will lose its “meaningful” suffix, which was derived from the license holder’s name; it likely will be designated as filgrastim-bflm. Etanercept-szzs (Erelzi; Sandoz) will need a new suffix that has at least three distinct letters. The guidance does not specify a timeline for changing the nonproprietary names of previously approved biologics.
These requirements also come despite opposition from industry, health care professionals, and other stakeholders who voiced support for meaningful and memorable suffixes. Soon after the final guidance was released on January 12, both the Biosimilars Forum and the Biologics Prescribers Collaborative issued press releases expressing disappointment and concern about the decision to use meaningless suffixes.
The guidance does not include a naming convention for interchangeable products. Instead, it states that “FDA continues to consider the appropriate suffix format” for interchangeable products.