The U.S. Food and Drug Administration proposed new draft guidance to streamline biosimilar development, indicating the agency will no longer routinely require comparative clinical efficacy trials for many biosimilars. FDA officials said the change is intended to lower development costs, shorten timelines, and increase market competition for complex biologics. Officials including Commissioner Marty Makary framed the policy shift as a step toward making biosimilars “more like generics,” a change that could reshape pricing and access dynamics for high‑cost biologics. Industry analysts expect the move to encourage more entrants and speed substitution at the pharmacy level, while patient groups and originator companies will likely press for clarity on interchangeability standards and post‑market safety surveillance.