Sec. 4004. Modernizing the reporting of biological and biosimilar products

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Subtitle B of title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ) is amended— in section 1111, as amended by section 3(1) of the Patient Right to Know Drug Prices Act— in the paragraph

(3)inserted by such section 3(1), by striking an application and inserting a biosimilar biological product application ; in the paragraph

(4)inserted by such section 3(1), by inserting application before under section 351(k) of the Public Health Service Act ; in the paragraph

(5)inserted by such section 3(1), by striking for licensure of a biological product under section 351(k) of the Public Health Service Act and inserting 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 ; in paragraph (7), as redesignated and amended by such section 3(1), by striking or under section 351(a) of the Public Health Service Act and inserting 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 ; and in the paragraph

(12)added by such section 3(1), by striking means a brand name drug for which a license is in effect under section 351(a) and inserting has the meaning given such term in section 351(i) ; and in section 1112, as amended by section 3(2) of the Patient Right to Know Drug Prices Act— in subsection (a)— in paragraph (1), by striking for which a statement under section 351(l)(3)(B)(ii)(I) of the Public Health Service Act has been provided ; in paragraph (2)— in subparagraph (C)(i), by striking brand name and inserting listed ; and by amending clause

(ii)of subparagraph

(C)to read as follows: any of the time periods referred to in section 351(k)(6) of the Public Health Service Act as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product. ; in subsection (b)— in the subsection heading, by inserting after or Biosimilar Biological Product Applicant ; Applicant in paragraph (1)(B), by striking the first sentence and inserting the following: A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). ; and in paragraph (2)— by striking 2 generic drug applicants and inserting 2 or more generic drug applicants ; and by striking or an agreement between 2 biosimilar biological product applicants regarding the 1-year period referred to in section 351(k)(6)(A) of the Public Health Service Act as it applies to the biosimilar biological product applications with which the agreement is concerned and inserting , an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product ; and in subsection (c)(2), by inserting were entered into within 30 days of, after condition for, .

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Pub. L. 108-173

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Sec. 4004

Modernizing the reporting of biological and biosimilar products

Pub. L.Pub. L. 108-173

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