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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).

Entitlement Program

Programs for people who have a federal right to benefits if eligibility criteria is met. Changes to the eligibility for these programs must be done…