Story perspectives

FDA Eases Biosimilar Regulations to Slash Drug Prices

11/1/2025

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Summary

Story summary

On October 29, 2025, the Food and Drug Administration announced it will ease regulations for low-cost biosimilars to reduce drug prices.
FDA Commissioner Dr. Marty Makary said the rules could halve the approval timeline and cut costs.
Brand-name drugmakers have historically used patents and legal tactics to block biosimilars.
Health Secretary Robert F. Kennedy Jr. criticized these practices, while PhRMA cited pharmacy benefit managers as a barrier to biosimilar adoption.

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Story summary

On October 29, 2025, the Food and Drug Administration announced it will ease regulations for low-cost biosimilars to reduce drug prices.
FDA Commissioner Dr. Marty Makary said the rules could halve the approval timeline and cut costs.
Brand-name drugmakers have historically used patents and legal tactics to block biosimilars.
Health Secretary Robert F. Kennedy Jr. criticized these practices, while PhRMA cited pharmacy benefit managers as a barrier to biosimilar adoption.