1. Short title This Act may be cited as the Biosimilars Competition Act of 2018 . 2. Licensure pathway for biosimilar biological products Section 351(l) of the Public Health Service Act ( 42 U.S.C. 262(l) ) is amended by adding at the end the following: (10) Notification of agreements (A) Requirements (i) Agreement between biosimilar product applicant and reference product sponsor If a subsection (k) applicant and the reference product sponsor enter into an agreement described in subparagraph (B), the applicant and sponsor shall each file the agreement in accordance with subparagraph (C). (ii) Agreement between biosimilar product applicants If 2 or more subsection (k) applicants for biosimilar products with the same reference product enter into an agreement described in subparagraph (B), the applicants shall each file the agreement in accordance with subparagraph (C). (B) Subject matter of agreement An agreement described in this subparagraph— (i) is an agreement between a subsection (k) applicant and the reference product sponsor or between 2 or more subsection (k) applicants regarding the manufacture, marketing, or sale of— (I) the biosimilar product (or biosimilar products) for which an application was submitted under subsection (k); or (II) the reference product; (ii) includes any agreement between a subsection (k) applicant and the reference product sponsor or between 2 or more subsection (k) applicants that is contingent upon, provides a contingent condition for, or otherwise relates to an agreement described in clause (i); and (iii) excludes any agreement that solely concerns— (I) purchase orders for raw material supplies; (II) equipment and facility contracts; (III) employment or consulting contracts