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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).

National Plan and Provider Enumeration System (NPPES)

The administrative system for supporting a national plan and provider registry. A comprehensive uniform system for identifying and uniquely enumerating health care providers and plans…