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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).

Federally Qualified Health Center (FQHC)

A health care setting that meets requirements under HHS to receive additional reimbursement to carry out their mission of providing primary care services to underserved…