The U.S. Food and Drug Administration issued new draft guidance to speed approval of biosimilars by reducing or removing requirements for comparative Phase III efficacy studies. Agency leaders signaled the change as a policy lever to drive competition and lower drug prices, framing the guidance as a way to cut development time and cost for copycat biologics. FDA Commissioner Marty Makary and Center for Drug Evaluation and Research officials described the move at a public briefing and in draft documents, saying developers can rely more on analytical, pharmacokinetic and immunogenicity data to demonstrate biosimilarity. The agency plans a final guidance within months and will accept public comment on the draft. Developers and payers will likely see faster market entry for biosimilars and a narrower path to interchangeability and pharmacy substitution; manufacturers of originator biologics have warned the change could affect revenue and lifecycle strategies. Clarification: biosimilars are complex biologic medicines designed to be highly similar to an approved reference product, but not identical in the way small‑molecule generics are.