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FDA Proposes Ending Redundant Biosimilar Trials, Cutting Costs 50%

By Drooid · Oct 16, 2026, 3:58 PM UTC · How we work

Summary

Story summary

The U.S. Food and Drug Administration (FDA) proposes ending redundant biosimilar trials when scientific evidence already shows similarity.
In March 2026 the FDA issued draft recommendations to cut pharmacokinetic study costs by up to 50%, about $20 million.
The October 2025 draft guidance said comparative efficacy studies may be unnecessary if other data prove biosimilarity.
FDA data show biologics comprised 51% of U.S. drug spending in 2024 but only 5% of prescriptions.

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Story summary

The U.S. Food and Drug Administration (FDA) proposes ending redundant biosimilar trials when scientific evidence already shows similarity.
In March 2026 the FDA issued draft recommendations to cut pharmacokinetic study costs by up to 50%, about $20 million.
The October 2025 draft guidance said comparative efficacy studies may be unnecessary if other data prove biosimilarity.
FDA data show biologics comprised 51% of U.S. drug spending in 2024 but only 5% of prescriptions.