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FDA news: Challenges in naming biosimilars

The FDA has recently announced draft guidance for nonproprietary naming of biosimilar drugs that has been long awaited across the industry. Two main concerns driving their initial ruling include the restriction of product substitution as well as worry over medication error and safety.

The FDA’s proposed solution seemingly solves both challenges by allowing for a non-proprietary name with a root that is identical for both the biosimilar and the reference drug but also requiring a four letter suffix that is attached to the root name and unique to each compound. This guidance achieves two goals, communicating the inherent similarity between a biosimilar and a reference product while allowing for differentiation between the two. It also opens the door for a discussion around the role of the manufacturer as a choice driver for prescribers. Although the draft guidance states that the 4-letter suffix can not be derived from the manufacturer’s name there is nothing stated yet that limits the use of the same 4-letter suffix across multiple products by the same manufacturer. While it is unclear why the FDA feels it is necessary to avoid signaling a manufacturer in the suffix of the name in the first place for now, this could be a good idea for the manufacturer. If a 4-letter suffix were to be used by the same manufacturer thereby signaling a portfolio of biosimilar products, it may help prescribers remember their product preferences. It remains to be seen whether choice can be driven by manufacturer, secondary to product MOA, but represents an opportunity to drive clarity and simplicity for both drug developers as well as prescribers in this dynamic drug naming landscape.


Creative Director, Identity