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FDA Unveils Guidance to Cut Biosimilar Development Costs

3/10/2026

Summary

Story summary

On March 9, 2026, the U.S. Food and Drug Administration released guidance to help drugmakers develop biosimilars.
Biosimilars account for 5% of prescriptions but 51% of drug spending.
The guidance aims to streamline studies on drug interactions and could cut development costs by 50% or $20 million.
FDA Commissioner Marty Makary emphasized the agency's commitment to reducing drug costs for Americans.
The guidance withdraws a 2015 document on biosimilar matching.

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Story summary

On March 9, 2026, the U.S. Food and Drug Administration released guidance to help drugmakers develop biosimilars.
Biosimilars account for 5% of prescriptions but 51% of drug spending.
The guidance aims to streamline studies on drug interactions and could cut development costs by 50% or $20 million.
FDA Commissioner Marty Makary emphasized the agency's commitment to reducing drug costs for Americans.
The guidance withdraws a 2015 document on biosimilar matching.