JAMA Internal Medicine  |  November 28, 2022

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Analogous to generic drugs, biosimilars are versions of biologic drugs made by other manufacturers that help stimulate price competition after the biologic’s market exclusivity ends. Although biologics comprise fewer than 5% of prescription drug use, they account for approximately 40% of US drug spending. Biologic manufacturers often take steps to delay availability of biosimilars, including by obtaining patents and regulatory exclusivities for supplemental indications that expire years after those covering the biologic’s original indications. To help prevent this source of potential delay, federal law permits the US Food and Drug Administration (FDA) to approve “skinny-label” generic drugs and biosimilars that carve out indications protected by patents or regulatory exclusivities. With recent court rulings threatening the skinny-label pathway, we assessed the frequency of approval and marketing of skinny-label biosimilars and their savings to Medicare.

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