The FDA proposed draft guidance to remove the routine requirement for comparative clinical efficacy trials in many biosimilar applications, aiming to shorten development timelines and lower costs for copycat biologics. The agency framed the move as a way to increase market competition and reduce drug prices by making biosimilar development more like generics. FDA officials signaled the change would rely more on analytical, pharmacokinetic and pharmacodynamic evidence plus robust analytical similarity data. Commissioner Marty Makary said the policy intends to spur biosimilar entries and pharmacy substitution. Biosimilars are complex biologic comparisons, not identical generics; the proposal preserves case-by-case clinical requirements where uncertainty remains. If finalized, the guidance could materially lower barriers for companies developing lower-cost biologics.