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Biosimilars User Fee Act

Creates an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).

Supplemental Medical Insurance (SMI) Trust Fund

Pays for Medicare Part B and Part D and funding via patient premiums and general revenue.