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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).

Self-Insured Individual

An individual who decides (and is financially able) to cover their own medical costs without an insurance plan. Those that chose to self-insure will owe…