The U.S. Food and Drug Administration unveiled a draft framework proposing to eliminate routine Phase III comparative efficacy trials for biosimilar approvals. The agency, led by Commissioner Marty Makary, argues the change will cut development time and cost for copycat biologics and encourage competition. The proposal clarifies when clinical data would still be required and solicits public comment ahead of final guidance. Industry groups and biosimilar developers welcomed the proposal as a potential shortcut to market, while some clinicians and patient advocates urged caution and asked for clarity on interchangeability and immunogenicity assessment. The guidance reflects a regulatory shift to treat complex biologic copies more like small-molecule generics where appropriate. Biosimilars are biologic medicines highly similar to an already-approved reference product; reducing duplicative trials could change cost structures and commercial strategies for large and small developers alike. The FDA intends to finalize the guidance in the coming months after stakeholder input.