“To improve the requirements for making a determination of interchangeability of a biological product and its reference product.”
No CRS summary available for this bill.
This section revises the biosimilar licensure pathway under section 351(k) of the Public Health Service Act by eliminating the separate "interchangeable" designation in the subsection heading and application requirements; streamlining the standards for licensure to require only a demonstration of biosimilarity to the reference product; and deeming all licensed biosimilars interchangeable either upon licensure (if on or after the transition date, defined as 60 days after enactment) or on the transition date (if licensed earlier), subject to any unexpired first interchangeable exclusivity period (typically 1 year) for the first such biosimilar on the same reference product that was licensed before enactment. The section preserves such pre-enactment exclusivity periods; removes certain reporting and criteria related to interchangeability; and makes conforming amendments to related provisions, including pediatric assessment requirements under section 505B(l) of the Federal Food, Drug, and Cosmetic Act (thus applying those requirements uniformly to all biosimilars licensed under section 351(k)).