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8h ago

FDA Moves to Speed Biosimilar Approvals With Draft Guidance Easing Trials

Patient savings hinge on payer policies, PBM formularies, plus state substitution rules.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
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Young female scientist conducting research in a lab
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Overview

  • The FDA released draft guidance allowing advanced analytical testing to replace many comparative human efficacy studies in biosimilar applications.
  • The agency said it will generally recommend against switching studies for interchangeability, enabling pharmacist substitution where state law permits.
  • Officials projected development timelines could be cut roughly in half with about $100 million in savings per product.
  • Biologics represent about 5% of prescriptions yet roughly 51% of drug spending; 76 biosimilars have been approved in the U.S. with market share below 20%.
  • The guidance is non-binding with a 60-day public comment period, and final guidance is expected in approximately three to six months as part of a wider drug-price push by the Trump administration.