The US Food and Drug Administration unveiled draft guidance proposing to eliminate routine Phase III comparative efficacy studies for many biosimilar submissions, aiming to lower development cost and shorten time‑to‑market. FDA Commissioner Marty Makary and agency statements framed the change as a path to broaden competition and reduce drug prices; the draft will undergo comment and is expected to be finalized within months. The proposal clarifies when clinical efficacy trials remain necessary and how analytical and pharmacokinetic data can substitute; biosimilars are follow‑on biologics designed to match safety and efficacy of approved reference biologics.