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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).

Data Collection and Health Care Disparities

New requirements for reporting of treatment data on race, sex, primary language, disability status, and location designed to target and minimize treatment disparities between groups.