Exploring the FDA's Clarification on Biosimilar Labeling

Biosimilar drugs are highly similar to, but not exact duplicates of existing biologics, rendering them different from more common small-molecule generics. In an article published in Law360, Faegre Baker Daniels partner Jessica Benson Cox and associate Munjot Sahu discussed the FDA’s previous and current position on the issues surrounding biosimilar labeling.

“The FDA approved the first biosimilar in the United States…in March 2015,” the authors said. “The FDA’s approach to labeling this product, however, left many in the industry with questions (and concerns) about how the FDA might approach the labeling of biosimilars in the future.”