The FDA published draft guidance proposing to eliminate routine comparative clinical efficacy studies for many biosimilar applications, a move intended to shorten development timelines and lower costs for copycat biologics. Agency officials said the change will reduce unnecessary trials where robust analytical and pharmacokinetic/pharmacodynamic data can demonstrate biosimilarity, mirroring how generics are developed. FDA Commissioner and senior staff framed the proposal as a competition and access measure to drive down biologic drug costs. The draft guidance will enter a public comment period before finalization, and industry stakeholders expect debate over interchangeability standards, pharmacovigilance and the circumstances under which clinical endpoints remain necessary. If finalized, the policy could accelerate biosimilar launches, increase competition in biologics categories and reshape payer and manufacturer strategies for large‑priced therapies.