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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).

Payment Error Rate Measurement (PERM)

The measure of the improper payments of Medicaid and CHIP, which results in an error rate for each program. These rates are based on multiple…