Senior FDA leadership signaled further 'deregulatory' actions following recent steps to relax biosimilar clinical requirements, and the agency formally proposed removing mandatory clinical efficacy trials for many biosimilar applications. FDA Commissioner comments indicate a regulatory agenda to streamline development pathways, reduce duplicative testing, and accelerate market entry for follow‑on biologics. The biosimilar proposal would align regulatory burdens more closely with small‑molecule generics, substituting analytical and pharmacokinetic comparability for some clinical efficacy studies—moves that biopharma and payer stakeholders argue could cut costs and speed access but that critics warn may require careful pharmacovigilance and interchangeability safeguards.