The U.S. Food and Drug Administration issued draft guidance permitting sponsors to use comparator data from non‑U.S. reference products in certain biosimilar development programs, the agency said. The change would allow companies to rely on established foreign comparator datasets when the U.S. reference is not essential, reducing redundant bridging studies and potentially lowering time and cost of biosimilar development. Biosimilars are complex biologic copies that require comparative analytical and clinical evidence; accepting foreign comparator data streamlines global development alignment. The draft guidance signals regulatory intent to expand competition in biologics markets by lowering development hurdles, subject to public comment and finalization.