Rewrites federal rules for biosimilar biological products by reorganizing and updating the approval, interchangeability, and exclusivity rules that apply to biosimilars under existing law. It also makes related technical edits across statutes and requires the FDA (the Secretary) to issue updated guidance within specified timeframes so the new rules are reflected in agency practice.

The changes affect what data and statements must be in a biosimilar application, how and when a biosimilar may be designated interchangeable with its reference product, how existing exclusivity is preserved, and several cross-references in FDA law to keep the statute consistent with the new structure.