Misleading and Deceptive? A Look into Educational and Promotional Messages Comparing the Nature of Biologics and Biosimilars 

Francisco Lemos Ribeiro Filho


This Article assesses the legal issues arising from claims that companies commercializing original biological medicines (biologics) have disseminated messages to mislead the public into believing biosimilars are less safe and effective than their reference biologics. Pfizer raised those concerns to the Food and Drug Administration (FDA) and asked the agency to establish standards for communication comparing the nature and properties of biologics and biosimilars. Other players followed suit, arguing the Federal Trade Commission (FTC) should also intervene. In 2020, FDA issued draft guidance on the matter, only partially fulfilling Pfizer’s request, while FTC threatened enforcement action. Specifically, this Article analyzes FDA and FTC’s regulatory and enforcement limitations preventing the agencies from fully addressing the demands from those concerned that biosimilars have been improperly discredited. The conclusion provides insights on how FDA-led educational initiatives and a different antitrust focus may help with the biosimilars uptake in the United States.