Sec. 1111. DEFINITIONS

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## SEC. 1111 DEFINITIONS In this subtitle: ####

(1)ANDA The term “**ANDA**” means an abbreviated drug application, as defined under section 201(aa) of the Federal Food, Drug, and Cosmetic Act. ####

(2)Assistant attorney general The term “**Assistant Attorney General**” means the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice. ####

(3)Biosimilar biological product The term “**biosimilar biological product**” means a biological product for which a biosimilar biological product application under section 351(k) of the Public Health Service Act is approved. ####

(4)Biosimilar biological product applicant The term “**biosimilar biological product applicant**” means a person who has filed or received approval for a biosimilar biological product application under section 351(k) of the Public Health Service Act. ####

(5)Biosimilar biological product application The term “**biosimilar biological product application**” means an application under section 351(k) of the Public Health Service Act for licensure of a biological product as biosimilar to, or interchangeable with, a reference product. ####

(6)Brand name drug The term “**brand name drug**” means a drug for which an application is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act, including an application referred to in section 505(b)(2) of such Act, or a biological product for which an application is approved under section 351(a) of the Public Health Service Act. ####

(7)Brand name drug company The term “**brand name drug company**” means the party that holds the approved application referred to in paragraph

(6)for a brand name drug that is a listed drug in an ANDA or a reference product in a biosimilar biological product application, or a party that is the owner of a patent for which information is submitted for such drug under subsection

(b)or

(c)of section 505 of the Federal Food, Drug, and Cosmetic Act or the owner, or exclusive licensee, of a patent included in a list provided under section 351(l)(3) of the Public Health Service Act. ####

(8)Commission The term “**Commission**” means the Federal Trade Commission. ####

(9)Generic drug The term “**generic drug**” means a drug for which an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act is approved. ####

(10)Generic drug applicant The term “**generic drug applicant**” means a person who has filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act. ####

(11)Listed drug The term “**listed drug**” means a brand name drug that is listed under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act. ####

(12)Reference product The term “**reference product**”has the meaning given such term in section 351(i) of the Public Health Service Act.