USA – Biologic and Biosimilar Misinformation: FDA Drafts Guidance

Since at least 2018, various industry groups and biopharma companies have highlighted the ways that the truth has been stretched around biosimilars and their reference products, and they have sought help from the US Food and Drug Administration (FDA) in setting the record straight.

FDA on Monday offered some help in the way of a new draft guidance, with eight questions and answers explaining how companies can promote reference or biosimilar products in truthful and non-misleading ways. But the agency did not single out specific violations or point to real world examples of misinformation.

“Although assessment of each promotional presentation involves a fact specific determination, representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar, such as promotional presentations representing or suggesting that a reference product is safer or more effective than its biosimilar product, or that a biosimilar is safer or more effective than its reference product are likely to be false or misleading. Similarly, representations or suggestions that create an impression that a biosimilar is not highly similar to its reference product are likely to be false or misleading,” the 10-page draft guidance says…