The U.S. Food and Drug Administration issued draft guidance proposing to remove the routine requirement for comparative clinical efficacy (Phase 3) trials for biosimilars, a move intended to accelerate market entry and lower development costs. Agency officials framed the change as an effort to speed competition into biologic markets and reduce drug prices. The proposal would permit sponsors to rely on analytical, functional and pharmacokinetic/pharmacodynamic comparability packages to demonstrate biosimilarity in many cases. Biosimilars are complex biologics that require a higher bar than small‑molecule generics; the FDA’s draft guidance clarifies when clinical efficacy endpoints may be unnecessary while preserving standards for safety and immunogenicity. Industry impact will be immediate: sponsors can cut time and cost to commercialization, payers may see faster competition, and developers of originator biologics will face accelerated erosion risk. Regulators and stakeholders will still weigh appropriate evidentiary thresholds for interchangeability and post-market surveillance.