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Fact Sheet

Biologics in Perspective

The New Biosimilar Approval Pathway

In the United States, spending on expensive biologic drugs is growing more than ten times faster than spending on traditionally-developed “small molecule” drugs. This AARP Public Policy Institute fact sheet by Leigh Purvis examines provisions in the Affordable Care Act that created an approval pathway for generic versions of biologic drugs, or biosimilars, but ensured that brand name biologic manufacturers are protected from this new competition for at least 12 years. Drug manufacturer sales data show that most top-selling biologics can recoup their manufacturer’s development costs in a single year.

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