FDA’s Draft Guidance on Promotional Labeling and Advertising Considerations

Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues unique to interchangeable biosimilars.

The draft guidance addresses the “general requirements for the content of FDA-regulated promotional materials for reference products and biosimilars products.” This determination is “fact-specific” and “takes into account such factors as how the information is presented, the type and quality of the data relied on to support the presentation, and contextual and disclosure considerations.” Prompt revisions to promotional labeling and advertising may be required upon certain labeling changes.

The draft guidance includes a number of ways, “depending on context,” in which “firms [may] identify reference products and biosimilar products in promotional materials,” including by “their proprietary name, nonproprietary name or proper name, or core name.” The draft guidance provides definitions of each such name. Firms must take special care to accurately identify the relevant biological (reference or biosimilar) product or products in promotional materials.

The draft guidance also describes what firms should consider “when developing promotional materials for biosimilars.” Question 3 addresses what should be considered “if presenting information from the studies conducted to support license of the reference product when the information is included in the FDA-approved labeling of both the reference and the biosimilar products” and Question 4 addresses what should be considered “if presenting data or information from studies conducted to support a demonstration of biosimilarity when the data or information is not included in the FDA-approved labeling for their biosimilar product.” (Emphases added).

As FDA’s licensure of a biosimilar product indicates it has deemed the biosimilar to be “highly similar to the reference product”, the guidance makes clear “that representations or suggestions that create an impression that there are clinically meaningful differences…are likely to be misleading.” Specifically, the guidance states that representations that either the reference product or the biosimilar is “safer or more effective” than the other is likely to be misleading.

Further, the draft guidance states that even statements of accurate information about a reference product or biosimilar could contribute to a misleading presentation. Specifically, “presentations in promotional materials for a reference product comparing the number of indications for which the reference product is licensed to the number of indications for which the biosimilar is licensed in a manner that creates the net impression that the biosimilar product is in general less safe or less effective than the reference product simply because the biosimilar is licensed for fewer indications than the reference product would be misleading.” FDA further concludes that promotional materials should not suggest a biosimilar is less safe than the reference product because it was not licensed as an interchangeable.

We will continue to monitor this draft guidance and provide updates as they are available.