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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).

Medical Home

Patients receive primary care services, an ongoing relationship with a primary care provider, and enhanced access to nonemergent primary, secondary and tertiary care in this…