§379j–51 Definitions

Summary

Explains what key words mean for the rules about reviewing biosimilar biological products and collecting fees. Adjustment factor is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by that Index for September 2011. Affiliate means a business that controls or can control another business, or both are controlled by the same third party. Biosimilar biological product means a specific strength of a biological product in final dosage form that has an approved biosimilar application. Biosimilar biological product application means an application for licensure under section 262(k) of title 42, but it does not include supplements, certain applications citing reference products licensed before September 1, 1992 (like a bovine blood topical product or a large volume parenteral drug), applications for whole blood or blood components for transfusion, in vitro diagnostic biological products, products for further manufacturing only, or applications submitted by a State or Federal government entity for products not distributed commercially. Biosimilar biological product development meeting means any meeting (other than an initial advisory meeting) about a development program, including study design or study data. Biosimilar biological product development program means the program under this subpart to speed up review of submissions for biosimilar development. Biosimilar biological product establishment means a single location (one or more buildings within 5 miles of each other) where one or more biosimilar products are manufactured in final dosage form; “manufactured” does not include packaging. Biosimilar initial advisory meeting means a requested meeting limited to a general talk about whether licensure under section 262(k) may be feasible and general advice on the development program; it does not include meetings that review summary data or full study reports. Costs of resources allocated for the process for the review of biosimilar biological product applications means the expenses tied to review work, including FDA staff and contractors, advisory committees, IT and computer systems, facilities and equipment, and collecting fees and accounting. Final dosage form means a finished form approved for use by a patient without more manufacturing (for example, lyophilized products before reconstitution). Financial hold means an order by the Secretary stopping a sponsor from continuing an investigation intended to support a biosimilar application if the sponsor failed to pay any fee required 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 an affiliate. Process for the review of biosimilar biological product applications covers the Secretary’s work to review submissions and supplements, issue action letters approving or listing deficiencies, inspect establishments, release lots under section 262(k) of title 42, monitor related research, and carry out postmarket safety activities (including collecting and reviewing adverse-event reports, improving data systems and tools, and implementing sections 355(o), 355(p), and 355(k)(5)). Supplement means a request to the Secretary to approve a change to an approved biosimilar application, including a request to decide if the product meets the interchangeability standard in section 262(k)(4) of title 42.