21 U.S.C. § 379j–51 — Definitions

This section defines the terms used in the biosimilar user fee law. (1) "Adjustment factor" for a fiscal year is the Consumer Price Index for urban consumers in the Washington-Arlington-Alexandria area (not seasonally adjusted, all items) for September of the prior fiscal year, divided by that same index for September 2011. (2) "Affiliate" means a business connected to a second business if either one controls (or can control) the other, or a third party controls (or can control) both. (3) "Biosimilar biological product" means a specific strength of a biological product, in its final dosage form, whose biosimilar application has been approved. (4) "Biosimilar biological product application" generally means an application to license a biological product under section 262(k) of title 42. But it does not include: a supplement to such an application; an application under section 262(k) that names as its reference product a bovine blood product for topical use licensed before September 1, 1992, or a large-volume parenteral drug approved before that date; an application under section 262(k) for whole blood or blood components for transfusion, an in-vitro diagnostic biological product, or a biological product meant only for further manufacturing; or a section 262(k) application filed by a state or federal government entity for a product that isn't sold commercially. (5) "Biosimilar biological product development meeting" means any meeting about the content of a development program — including a proposed study design or study data — other than a biosimilar initial advisory meeting. (6) "Biosimilar biological product development program" means the program under this subpart for speeding up review of biosimilar development submissions. (7) "Biosimilar biological product establishment" means a foreign or domestic place of business at one general location (all buildings within 5 miles of each other) where one or more biosimilar products are made in final dosage form. For this purpose, "manufactured" does not include packaging. (8) "Biosimilar initial advisory meeting" means a requested meeting limited to a general discussion of whether licensing might be feasible for a particular product, and, if so, general advice on what the development program should cover. It does not include any meeting that substantively reviews summary data or full study reports. (9) "Costs of resources allocated for the process for the review of biosimilar biological product applications" means the FDA's expenses for: (A) officers, employees, contractors, and advisory committees involved in this review, and related costs; (B) managing information and acquiring, maintaining, and repairing computer resources; (C) leasing, maintaining, renovating, and repairing facilities, and acquiring, maintaining, and repairing fixtures, furniture, scientific equipment, and other necessary supplies; and (D) collecting the fees under section 379j–52 and tracking how the resources are used. (10) "Final dosage form" means, for a biosimilar product, a finished form ready to give to a patient without major further manufacturing — such as a freeze-dried (lyophilized) product before it is mixed with liquid. (11) "Financial hold" means an order stopping a clinical trial's sponsor from continuing the trial, issued because the Secretary decided the trial supports a biosimilar application and the sponsor failed to pay a required fee under subparagraph (A), (B), or (D) of section 379j–52(a)(1). It is different from a "clinical hold" under section 355(i)(3), which rests on other legal grounds. (12) "Person" includes a person's affiliate. (13) "Process for the review of biosimilar biological product applications" covers: (A) the activities needed to review biosimilar development submissions, applications, and supplements; (B) related actions, including issuing letters that approve applications or spell out their specific deficiencies, and helping applications become approvable; (C) inspecting biosimilar manufacturing facilities as part of reviewing pending applications and supplements; (D) releasing batches ("lots") of biosimilar products under section 262(k) of title 42; (E) monitoring research connected to reviewing biosimilar applications; and (F) postmarket safety work, including collecting, developing, and reviewing safety information such as adverse-event reports; building better adverse-event data-collection systems, including information technology; building better analytical tools to spot safety problems, including access to outside databases; and carrying out the laws on postapproval studies, clinical trials, and labeling changes, on risk evaluation and mitigation strategies, and on adverse-event reporting and postmarket safety. (14) "Supplement" means a request to the Secretary to change an already-approved biosimilar application, including a request that the Secretary find the biosimilar product meets the standards for interchangeability under section 262(k)(4) of title 42.