The U.S. Food and Drug Administration published draft guidance aiming to streamline biosimilar approvals by no longer routinely requiring head‑to‑head clinical efficacy studies against branded biologics. FDA officials, led by Commissioner Marty Makary, said the policy change will shorten development timelines and lower costs for biosimilar makers. The agency said sponsors can rely more on analytical, pharmacokinetic and immunogenicity data to demonstrate biosimilarity rather than large Phase 3 trials. FDA staff signaled a rapid finalization timeline, with the expectation of concluding guidance within months. If finalized, the shift could accelerate competition for high‑cost biologics, expand pharmacy substitution opportunities, and compress the commercial runway for branded biologics. Biotech and payer stakeholders will be monitoring how the guidance affects interchangeability rules, reimbursement, and investment incentives for biosimilar development.