FDA Doubles Down in Its Updated Biologics Naming Guidance

Chad Landmon, JD, is a partner at Axinn, where he chairs the firm’s FDA and intellectual property practice groups. He regularly works with companies developing drugs, biologics, and regenerative medicine and human tissue products. Jonathan Knowles, JD, is an associate at Axinn. At this time, his admission to the New York bar is pending.
March 19, 2019
Despite Juliet’s famous soliloquy, very much is in a name. Names are how doctors and patients identify medical products, including drugs and biologics, and are a means for developers to communicate the quality of those products. The FDA has its own concerns about the names of medical products and regulates those names accordingly. Recently, the FDA updated its draft guidance on naming biologics, which will determine the nonproprietary names under which biosimilars must be sold the United States. Among other things, the FDA maintained its requirement that all newly licensed biologics include a 4-letter suffix to distinguish each product, and even extended this requirement to interchangeable biosimilars. This provision, among others, has stoked concerns in the biosimilars industry and in many circles concerned about lowering drug costs.

In the United States, innovative medical products often are referred to by 2 names: a proprietary name, which is chosen by the developer and is usually trademarked, and a nonproprietary name. In the generic drug context, the nonproprietary name is assigned to the drug substance. Thus, a branded drug product would often be referred to by its proprietary name, while each generic version of that product would share the same nonproprietary name. The purpose of this to provide clarity to patients, doctors, and payors as to which products contain the same drug substance, as well as to distinguish drug substances from one another.

The FDA has determined that the nonproprietary naming system will work differently for biologics. Under draft guidance released by the FDA in January 2017, which the more recent guidance updates, the nonproprietary names of all biologics (including biosimilars) will consist of a core name, which is designated by the US Adopted Names Council, and a 4-letter suffix. For biosimilars, the core name is the name of the so-called “novel” or “originator” biologic to which the biosimilar’s abbreviated Biologics License Application (aBLA) refers. The suffix is a meaningless combination of 4 lower case letters, affixed to the core name by a hyphen, which is proposed by the developer as part of the application. For example, Udenyca and Fulphila are biosimilars to Neulasta (which has the core name pegfilgrastim). They have the proper names pegfilgrastim-cbqv and pegfilgrastim-jmdb, respectively.

Although Neulasta’s core name has no suffix, it would need one if it were licensed today. Originator biologics require a suffix to avoid giving the false impression that they are safer or more effective than biosimilars. In the January 2017 guidance, the FDA stated its intention to apply its naming convention to biologics that were licensed before the guidance was released. The updated guidance is to the contrary, however. According to the new guidance, the FDA now believes that this practice would be unnecessarily confusing, and no longer plans to require that suffixes be added to previously licensed biologics or to transition products. The FDA is also reconsidering whether to require a proper name for vaccines.

Another major change from the previous guidance is the proper names of interchangeable products. The previous guidance left open whether interchangeable products, none of which were close to approval at the time, were to have their own suffixes or to share a suffix with the reference product. The new guidance requires interchangeable products to have their own suffixes. This practice is arguably inconsistent with the generic drug system under the Hatch-Waxman Act, in which all products that have been deemed by the FDA to be therapeutically equivalent share a nonproprietary name. One could argue that Congress, when it enacted the interchangeable provisions of the Biologics Price Competition and Innovation Act, intended similar treatment for interchangeable biologics.

The FDA’s reasoning, however, is that unique suffixes enhance pharmacovigilance by tracking a specific product to its manufacturer, although this raises questions as to why the FDA backtracked on its decision to require suffixes for previously licensed biologics. Although physician organizations have expressed support for this reasoning—including as applied to previously licensed products—it is not entirely clear whether unique suffixes actually help identify adverse reactions to products. Biosimilar developers are concerned that the suffix requirement, particularly in conjunction with the exception for previously licensed reference products, will undermine confidence in biosimilars and increase medical costs.

The Association for Accessible Medicines has called the suffix requirement “a significant, artificial barrier to biosimilars.” The International Generic and Biosimilars Association has pointed out that the FDA’s position differs from that taken by other countries, for example, Canada. There is evidence that physicians lack confidence in biosimilars generally, although it is too soon to see whether this will be true for interchangeable products.

The FDA will be taking comments on the updated guidance until July 5, 2019, after which point it will consider comments received and issue a final guidance. Given that it has stuck to its position on requiring suffixes generally in the recently updated draft guidance, the FDA seems unlikely to reconsider the basic naming structure, but it may reverse its course on previously licensed products or change the convention for interchangeable biosimilars. Interested companies and groups should certainly advocate their positions on these issues with the FDA and Congress before the FDA finalizes its guidance.




 

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