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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).

Large Group Plans

Large group plans generally provide health coverage to over 100 members of the same group such as a company, association or union.