The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used to treat serious and chronic diseases.

The agency is proposing major updates in a new draft guidance to simplify biosimilarity studies and reduce unnecessary clinical testing, and through a separate initiative, plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics. These combined efforts aim to help patients and pharmacists more easily choose lower-cost options.

Expensive biologic medications account for a significant share of healthcare spending, accounting for 51% of total drug spending in the U.S. as of 2024, despite representing only 5% of

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