Section 744G of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Biosimilar User Fee Act of 2012 (BsUFA), defines key terms pertaining to FDA’s biosimilar biological product user fee program.
A business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity, or a third party controls, or has power to control, both of the business entities. See section 744G(2).
Biosimilar biological product
A product for which a “biosimilar biological product application” (as such term is defined in section 744G(4)) has been approved. See section 744G(3).
Biosimilar biological product application
An application for licensure of a biological product under section 351(k) of the Public Health Service Act (PHS Act). This term does not include:
A supplement to such an application;
An application filed under section 351(k) of the PHS Act that cites as the reference product
a bovine blood product for topical application that was approved before September 1, 1992; or
a large volume parenteral drug product that was approved before September 1, 1992; or
An application filed under section 351(k) of the PHS Act with respect to
Whole blood or a blood component for transfusion;
An allergenic extract product;
An in vitro diagnostic biological product;
A biological product for further manufacturing use only; or
An application for licensure under section 351(k) of the PHS Act that is submitted by a state or federal government entity for a product that is not distributed commercially.
See section 744G(4).
Biosimilar biological product establishment
A foreign or domestic place of business that is at a one general physical location consisting of one or more buildings, all of which are within five miles of each other and at which one or more biosimilar biological products are manufactured in final dosage form. For purposes of this definition, the term “manufactured” does not include packaging. See section 744G(7).
Biosimilar biological product development (BPD) meeting
Any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application. For more information, please refer to the Biosimilar Biological Product Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017. See section 744G(5).
Biosimilar biological product development (BPD) program
FDA’s program for expediting the process for the review of submissions in connection with biosimilar biological product development. See section 744G(6).
Biosimilar initial advisory meeting
A meeting, if requested, that is limited to a general discussion regarding whether licensure under section 351(k) of the PHS may be feasible for a particular product, and if so, general advice on the expected content of the development program. This term does not include any meeting that involves substantive review of summary data or full study reports. For more information, please refer to the Biosimilar Biological Product Authorization Performance Goals and Procedures Fiscal Years 2013 through 2017. See section 744G(8).
Final dosage form
A finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution). See section 744G(10).
An order issued by FDA to prohibit the sponsor of a clinical investigation from continuing the investigation if FDA determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any required initial BPD fee, annual BPD fee, or reactivation fee for the product. The term financial hold does not mean that any of the bases for a “clinical hold” under section 505(i)(3) of the FD&C Act have been determined by FDA to exist concerning the investigation. See section 744G(11).
The term ‘person’ includes an affiliate of such person. See section 744G(12).
A request to FDA to approve a change in a biosimilar biological product application which has been approved. The term includes a supplement requesting a determination that the biosimilar biological product meets the standards for interchangeability in section 351(k)4 of the PHS Act. See section 744G(14).