Update on Naming Biosimilars
In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core” nonproprietary name of the product plus a unique four-letter suffix. Under the draft guidance, original biologics and biosimilar versions of them will have the same “core” names but different suffixes, and therefore distinct nonproprietary names. Controversially, last year’s draft guidance also recommends that the suffixes should be “devoid of meaning,” without reference to the maker of the product or to anything else recognizable or significant.
Earlier this month, FDA published a new notice in the Federal Register, proposing a new collection of information on the issue. While the new notice does not change the basic framework for biosimilar naming laid out in the draft guidance, it does revise the role of biologics makers in the nonproprietary naming process. In particular, FDA’s notice recommends that sponsors of biologic products submit ten suggested suffixes for their products under FDA’s proposed naming scheme. Previously, the agency had only asked sponsors to submit three proposed suffixes.
Although allowing biologics makers to make more suggestions might appear to afford them greater influence in the naming process, the change could end up having the opposite effect. As mentioned, under the previously announced guidance, the suffixes must be “devoid of meaning,” without any descriptive or identifying information. This widely-criticized policy represents a change from the scheme used for the first approved biosimilar, Sandoz’s Zarxio, which was assigned the nonproprietary name “filgrastim-sndz,” a reference to Sandoz. By asking sponsors to submit ten rather than three meaningless names, the new notice might make it harder for sponsors to focus on names that they believe have some marketing value. On the other hand, FDA did invite sponsors to rank their choices, so the new process may not dilute the sponsor’s influence so long as FDA is willing to take company preferences into account.
Interestingly, FDA notes in the new publication that many of the comments to last year’s proposed guidance “suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products.” Indeed, this was a rare point of agreement between makers of original biologics and makers of biosimilars, both of whom called for switching from meaningless suffixes to meaningful ones. It is not clear at this point whether FDA is open to revising its approach in response to industry feedback.
Like the August 2015 draft guidance, the new notice recommends that sponsors submit analyses explaining why their proposals are consistent with the factors FDA will consider in choosing a suffix. These factors state that in addition to being devoid of meaning a suffix should not:
• Be promotional, such as by making misrepresentations with respect to safety or efficacy
• 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 designated by the USAN Council
• Look similar to or be 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)
• Be too similar to any other product’s suffix designation
All in all, it is hard to see FDA’s recent update as reflecting any substantial changes in FDA’s approach to naming biologics. The one thing that is clear is that biologics makers will need to submit more suggestions and analysis to FDA regarding the nonproprietary names of their products.