The U.S. Food and Drug Administration published draft guidance proposing to eliminate routine comparative clinical efficacy trials for many biosimilars, a move designed to speed approvals and lower development costs. FDA officials said the change aims to increase competition and patient access by aligning some biosimilar requirements more closely with generics. Biosimilars are complex, near‑equivalent versions of biologic drugs; traditionally they have required comparative clinical testing to demonstrate no meaningful clinical differences. The guidance would rely more on analytical, functional and pharmacokinetic/pharmacodynamic data in lieu of Phase 3 efficacy studies where appropriate. The proposal is a draft and subject to public comment, but it signals a policy shift to accelerate entry of lower‑cost biologic competitors while maintaining evidence standards based on mechanistic and analytical similarity.