A New Guide for Promotional Labeling and Advertising of Biosimilar Products

Over the last few years, stakeholders in the biosimilar field have urged the FDA to address common questions related to promotional labeling and advertisements for biosimilar and reference products. On Feb. 3, 2020, the FDA published Guidance for Industry on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products addressing these common questions and provided recommendations for how to best develop and present promotional materials for biosimilars. In this article, Finnegan attorneys Brett Heavner and Kathryn Judson outline the central components of this new guidance as it relates to biologics labeling and promotional documents. While such materials are overseen by the FDA and governed by the laws within the Food, Drug and Cosmetic Act (FDCA), they also explore an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.

Read the full article here.