The FDA proposed a draft framework to lower the clinical development bar for biosimilars, including removing the routine requirement for comparative Phase 3 efficacy studies for some products. Commissioner Marty Makary framed the move as part of an administration effort to accelerate market entry and reduce drug costs by expanding biosimilar competition. The proposal would make biosimilar development more akin to generics for simpler molecules, cutting development time and expense and enabling faster pharmacy substitution in some cases. The draft guidance leaves open scientific and program‑specific determinations and invites public comment before finalization. Manufacturers and payers see the change as a potential lever to increase competition for high‑cost biologics; innovators warn about protecting product quality and immunogenicity assessment. Clarification: biosimilars are complex biologic copies that require analytical and clinical evidence to demonstrate similarity, unlike small‑molecule generics.