USFDA steps up biosimilar push to cut drug costs

The U.S. Food and Drug Administration (FDA) has announced major steps to make it faster and less costly to develop biosimilar medicines, lower-cost “generic” alternatives to biologic drugs used to treat serious and chronic diseases.

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In a new draft guidance, the FDA has proposed major updates aimed at simplifying biosimilarity studies and reducing unnecessary clinical testing-The agency also launched a separate initiative to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, allowing patients and pharmacists to choose affordable options more easily.It also noted that the expensive biologic drugs account for only 5 percent of prescriptions in the U.S. but make up 51 per cent of total drug spending as of 2024.Although FDA-approved biosimilars are as safe and effective as branded biologics, their market share remains below 20 per cent.