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Story perspectives

FDA Eases Biosimilar Approvals to Cut Drug Costs

11/20/2025

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Story summary
  • The U.S. FDA is streamlining biosimilar approvals to reduce testing requirements and development costs.
  • Biosimilars compete with biologics such as Humira and Trulicity, which cost patients between $10,000 and $30,000 annually.
  • Brand-name drug companies file numerous patents that create barriers for biosimilars to enter the market.
  • Even with FDA changes, price reductions depend on more non-brand options and insurer access, as formularies and patent disputes limit patients.