View all text of Subpart 8 [§ 379j-51 - § 379j-53]
§ 379j–51. DefinitionsFor purposes of this subpart:
(1) The term “adjustment factor” applicable to a fiscal year 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 such Index for September 2011.
(2) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(A) one business entity controls, or has the power to control, the other business entity; or
(B) a third party controls, or has power to control, both of the business entities.
(3) The term “biosimilar biological product” means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
(4)
(A) Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under section 262(k) of title 42.
(B) Such term does not include—
(i) a supplement to such an application;
(ii) an application filed under section 262(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;
(iii) an application filed under section 262(k) of title 42 with respect to—(I) whole blood or a blood component for transfusion;(II) an in vitro diagnostic biological product; or(III) a biological product for further manufacturing use only; or
(iv) an application for licensure under section 262(k) of title 42 that is submitted by a State or Federal Government entity for a product that is not distributed commercially.
(5) The term “biosimilar biological product development meeting” means any meeting, other than a biosimilar initial advisory meeting, regarding the span of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
(6) The term “biosimilar biological product development program” means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.
(7)
(A) The term “biosimilar biological product establishment” means a foreign or domestic place of business—
(i) that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
(ii) at which one or more biosimilar biological products are manufactured in final dosage form.
(B) For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.
(8) The term “biosimilar initial advisory meeting”—
(A) means a meeting, if requested, that is limited to—
(i) a general discussion regarding whether licensure under section 262(k) of title 42 may be feasible for a particular product; and
(ii) if so, general advice on the expected span of the development program; and
(B) does not include any meeting that involves substantive review of summary data or full study reports.
(9) The term “costs of resources allocated for the process for the review of biosimilar biological product applications” means the expenses in connection with the process for the review of biosimilar biological product applications for—
(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;
(B) management of information, and the acquisition, maintenance, and repair of computer resources;
(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
(D) collecting fees under section 379j–52 of this title and accounting for resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
(10) The term “final dosage form” means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).
(11) The term “financial hold”—
(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 379j–52(a)(1) of this title; and
(B) does not mean that any of the bases for a “clinical hold” under section 355(i)(3) of this title have been determined by the Secretary to exist concerning the investigation.
(12) The term “person” includes an affiliate of such person.
(13) The term “process for the review of biosimilar biological product applications” means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:
(A) The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
(B) Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.
(C) The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary’s review of pending biosimilar biological product applications and supplements.
(D) Activities necessary for the release of lots of biosimilar biological products under section 262(k) of title 42.
(E) Monitoring of research conducted in connection with the review of biosimilar biological product applications.
(F) Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:
(i) Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.
(ii) Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies).
(v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities).
(14) The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in section 262(k)(4) of title 42.
(June 25, 1938, ch. 675, § 744G, as added Pub. L. 112–144, title IV, § 402, July 9, 2012, 126 Stat. 1026; amended Pub. L. 115–52, title IV, § 402, Aug. 18, 2017, 131 Stat. 1028; Pub. L. 117–180, div. F, title IV, § 4002, Sept. 30, 2022, 136 Stat. 2160.)