“A bill 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 biological product licensure process under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) by (1) eliminating the separate "interchangeable" designation and requirements from the subsection heading, application contents, and approval standards; (2) deeming all biological products licensed under the subsection interchangeable with the reference product upon licensure (for those licensed on or after the transition date) or on the transition date (for those licensed before), where the transition date is 60 days after enactment, subject to any unexpired first interchangeable exclusivity periods for prior biosimilars relying on the same reference product; (3) preserving unexpired first interchangeable exclusivity periods for biological products licensed before enactment; and (4) making conforming amendments to related provisions, including excluding biosimilars licensed under subsection (k) from "new active ingredient" triggers for pediatric assessments under section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c). (As background, section 505B requires sponsors of applications for new drugs or biological products—including those with a new active ingredient—to submit pediatric assessments evaluating safety, effectiveness, dosing, and administration in pediatric subpopulations for relevant indications, which may be partially extrapolated from adult data.)