§379j–51 Definitions

Summary

Sets plain meanings for words used in the rules that speed up review of biosimilar drugs, collect fees, run meetings, and inspect places that make them. Adjustment factor — a ratio using the Consumer Price Index for urban consumers (Washington‑Arlington‑Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items): the value for September of the year before the fiscal year divided by the value for September 2011. Affiliate — a business that controls, is controlled by, or is controlled by the same party as another business. Biosimilar biological product — a specific strength of a biological medicine in its final form that has an approved biosimilar application. Biosimilar biological product application — an application under section 262(k) of title 42 to license a biosimilar, but not supplements and not applications tied to certain older bovine or large volume parenteral products (licensed or approved before September 1, 1992), whole blood or blood components for transfusion, in vitro diagnostics, products only for further manufacturing, or products submitted by a government entity that are not sold commercially. Biosimilar biological product development meeting — any meeting (other than the initial advisory meeting) about the content of a development plan, including study design or data. Biosimilar biological product development program — the program in this part to speed review of biosimilar submissions. Biosimilar biological product establishment — a single location (one or more buildings all within 5 miles) where one or more biosimilars are made in final dosage form; “manufactured” does not mean just packaging. Biosimilar initial advisory meeting — a requested meeting limited to a general talk about whether licensure under section 262(k) might be possible and general advice on the development program; it does not include detailed review of study data or full study reports. Costs of resources allocated for the process for the review of biosimilar biological product applications — FDA expenses for staff, contractors, advisory committees, IT and computer systems, facilities and equipment, supplies, and the work to collect and account for fees under section 379j–52. Final dosage form — a finished form approved to give to a patient without major extra manufacturing (for example, a lyophilized product before reconstitution). Financial hold — an order stopping a sponsor’s clinical study that is meant to support a biosimilar application if the sponsor did not pay required fees under subparagraph (A), (B), or (D) of section 379j–52(a)(1); it is not the same as a “clinical hold” under section 355(i)(3). Person — includes that person’s affiliates. Process for the review of biosimilar biological product applications — the FDA’s review activities, related actions and letters, inspections of establishments, lot‑release work under section 262(k), research monitoring, and postmarket safety work (including collecting and improving safety data, analytic tools, and enforcing sections 355(o), 355(p), and 355(k)(5)). Supplement — a request to FDA to approve a change in an approved biosimilar application, including a request to be found interchangeable under section 262(k)(4) of title 42.