In Law360, Analysis Group Authors Examine How New FDA Guidance Could Reshape Biosimilar Competition
April 3, 2026
In 2025, the US Food and Drug Administration (FDA) proposed updates to its biosimilarity guidance that could reshape the competitive landscape for biologics and biosimilars. By reducing certain clinical testing requirements and facilitating interchangeability designations, the FDA aims to accelerate biosimilar development and potentially expand patient access. However, the broader market and legal implications of the FDA’s guidance remain uncertain.
In a Law360 article, Analysis Group Managing Principal John Jarosz, Senior Advisor Richard Mortimer, and Manager Jason Doran examine the evolving US biosimilar landscape and place the FDA’s proposal in the broader context of biosimilar competition. Mr. Jarosz, Dr. Mortimer, and Mr. Doran explain that factors including prescriber preferences, drug pricing, and patent litigation may have contributed to adoption challenges for certain biosimilars. They situate the goals of the updates, which aim to address some of these challenges, in the context of several comments made by individuals and organizations during the FDA’s notice-and-comment procedure for the new guidance. Finally, they discuss how implementation of the updates may create additional challenges and uncertainties for biosimilar and branded drug manufacturers.
The authors conclude that while the FDA’s revisions could spur changes in approval timelines, certain downstream marketplace and legal uncertainties persist that could complicate shifts in manufacturer incentives and investment decisions.