A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and labeling for those meds.
The document (PDF) finalizes a draft guidance issued by the agency in April 2024 and replaces a previous guidance on the topic that was initially published in 2020.
Differences from last year’s draft version are minimal, including only an addition in the introduction that its recommendations “apply regardless of the medium of the communication (e.g., paper, digital)” and a few extra lines about considerations for comparisons between biosimilars and their reference products, along with “editorial changes for consistency, readability, and clarity,” per the FDA.
At the core of the guidance is a call for all promotional materials to be “accurate, truthful, and non-misleading.”
The bulk of the document, like its predecessors, is arranged in Q&A format, offering answers to nine questions that may arise in the creation of promotional ads and labeling for biologics and biosimilars.
On the topic of creating promotional communications for biosimilars, for example, the agency advised companies to draw from the meds’ FDA-approved labels rather than from those of their reference products.
In materials that compare biosimilars to their reference products, the regulator wrote, there should be no suggestion of any clinically meaningful differences in safety and effectiveness between the two, nor any impression that they’re anything but “highly similar,” including in cases where a biosimilar hasn’t been directly studied in all of its approved indications or where a biosimilar has been approved in fewer indications than its reference product.
Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is less safe or effective just because it hasn’t been licensed as interchangeable with the reference product.
The Q&A also includes several examples illustrating its recommendations, comprising scenarios that the FDA either would or wouldn’t determine to be misleading.
Though the guidance document outlines recommendations suggested by the FDA for compliance with its legal requirements, it’s technically legally nonbinding, and the agency noted that companies are free to take “an alternative approach” so long as it “satisfies the requirements of the applicable statutes and regulations.”