FDA Offers Advice on Labeling, Advertising of Biologics

Sponsors of biologics and biosimilars should carefully consider how they present safety and efficacy information in their promotional materials, the FDA said in a draft guidance.

Labeling or advertising should clearly distinguish which product the information applies to, whether it be the reference product, the biosimilar, or both, the agency said, adding that promotional material that suggests a biosimilar is safer or more effective than its reference product is “likely to be false or misleading.”

Clearly identifying the relevant products in promotional materials “can help prevent presentations that are inaccurate because they attribute data or information to the wrong product,” the agency said.