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FDA Streamlines Biosimilar Approvals, Promises Lower Drug Prices

10/29/2025

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Summary

Story summary

The U.S. Food and Drug Administration on October 29, 2025 announced plans to streamline biosimilar approvals.
The draft guidance would reduce the need for extensive human clinical trials by allowing analytical testing.
The reform could shorten the time to market for biosimilars from five to eight years and save $100 million.
Health and Human Services Secretary Robert F. Kennedy Jr. said the changes will boost competition and lower drug prices.

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Story summary

The U.S. Food and Drug Administration on October 29, 2025 announced plans to streamline biosimilar approvals.
The draft guidance would reduce the need for extensive human clinical trials by allowing analytical testing.
The reform could shorten the time to market for biosimilars from five to eight years and save $100 million.
Health and Human Services Secretary Robert F. Kennedy Jr. said the changes will boost competition and lower drug prices.