Title: Biosimilars Competition Act of 2018
Policy area: Health

Summary:
Biosimilars Competition Act of 2018
This bill amends the Public Health Service Act to require a biologic manufacturer and a biosimilar drug manufacturer to provide notification to the Department of Justice and the Federal Trade Commission regarding certain pharmaceutical agreements. The agreements requiring notice are those related to the manufacturer, marketing or sale of the biosimilar product or the reference product.
Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already-approved biological product.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6478 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6478

To enhance competition for prescription drugs by increasing the ability 
 of the Department of Justice and Federal Trade Commission to enforce 
existing antitrust laws regarding biologic and biosimilar products, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 23, 2018

   Mr. Sarbanes (for himself and Mr. Johnson of Ohio) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
To enhance competition for prescription drugs by increasing the ability 
 of the Department of Justice and Federal Trade Commission to enforce 
existing antitrust laws regarding biologic and biosimilar products, and 
                          for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Biosimilars Competition Act of 
2018''.

SEC. 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; or
                                    ``(IV) packaging and labeling 
                                contracts.
                    ``(C) Filing.--
                            ``(i) In general.--The text of an agreement 
                        required to be filed by subparagraph (A) shall 
                        be filed with the Assistant Attorney General in 
                        charge of the Antitrust Division of the 
                        Department of Justice (in this paragraph 
                        referred to as the `Assistant Attorney 
                        General') and the Federal Trade Commission not 
                        later than--
                                    ``(I) 10 business days after the 
                                date on which the agreement is 
                                executed; and
                                    ``(II) prior to the date of the 
                                first commercial marketing of, for 
                                agreements described in subparagraph 
                                (A)(i), the biosimilar product that is 
                                the subject of the application or, for 
                                agreements described in subparagraph 
                                (A)(ii), any biosimilar product that is 
                                the subject of an application described 
                                in such subparagraph.
                            ``(ii) If agreement not reduced to text.--
                        If an agreement required to be filed by 
                        subparagraph (A) has not been reduced to text, 
                        the persons required to file the agreement 
                        shall each file written descriptions of the 
                        agreement that are sufficient to disclose all 
                        the terms and conditions of the agreement.
                            ``(iii) Certification.--The chief executive 
                        officer or the company official responsible for 
                        negotiating any agreement required to be filed 
                        by subparagraph (A) shall include in any filing 
                        under this paragraph a certification as 
                        follows: `I declare under penalty of perjury 
                        that the following is true and correct: The 
                        materials filed with the Federal Trade 
                        Commission and the Department of Justice under 
                        section 351(l)(10) of the Public Health Service 
                        Act, with respect to the agreement referenced 
                        in this certification: (1) represent the 
                        complete, final, and exclusive agreement 
                        between the parties; (2) include any ancillary 
                        agreements that are contingent upon, provide a 
                        contingent condition for, or are otherwise 
                        related to, the referenced agreement; and (3) 
                        include written descriptions of any oral 
                        agreements, representations, commitments, or 
                        promises between the parties that are 
                        responsive to such section and have not been 
                        reduced to writing.'.
                    ``(D) Disclosure exemption.--Any information or 
                documentary material filed with the Assistant Attorney 
                General or the Federal Trade Commission pursuant to 
                this paragraph shall be exempt from disclosure under 
                section 552 of title 5, United States Code, and no such 
                information or documentary material may be made public, 
                except as may be relevant to any administrative or 
                judicial action or proceeding. Nothing in this 
                subparagraph prevents disclosure of information or 
                documentary material to either body of the Congress or 
                to any duly authorized committee or subcommittee of the 
                Congress.
                    ``(E) Enforcement.--
                            ``(i) Civil penalty.--Any person that 
                        violates a provision of this paragraph shall be 
                        liable for a civil penalty of not more than the 
                        maximum amount of a civil penalty under section 
                        1115(a) of the Medicare Prescription Drug, 
                        Improvement, and Modernization Act of 2003, as 
                        adjusted pursuant to applicable law, for each 
                        day during which such person is in violation of 
                        this paragraph. Such penalty may be recovered 
                        in a civil action--
                                    ``(I) brought by the United States; 
                                or
                                    ``(II) brought by the Federal Trade 
                                Commission in accordance with the 
                                procedures established in section 
                                16(a)(1) of the Federal Trade 
                                Commission Act.
                            ``(ii) Compliance and equitable relief.--If 
                        any person violates any provision of this 
                        paragraph, the United States district court may 
                        order compliance, and may grant such other 
                        equitable relief as the court in its discretion 
                        determines necessary or appropriate, upon 
                        application of the Assistant Attorney General 
                        or the Federal Trade Commission.
                    ``(F) Rulemaking.--The Federal Trade Commission, 
                with the concurrence of the Assistant Attorney General 
                and by rule in accordance with section 553 of title 5, 
                United States Code, consistent with the purposes of 
                this paragraph--
                            ``(i) may define the terms used in this 
                        paragraph;
                            ``(ii) may exempt classes of persons or 
                        agreements from the requirements of this 
                        paragraph; and
                            ``(iii) may prescribe such other rules as 
                        may be necessary and appropriate to carry out 
                        the purposes of this paragraph.
                    ``(G) Savings clause.--Any action taken by the 
                Assistant Attorney General or the Federal Trade 
                Commission, or any failure of the Assistant Attorney 
                General or the Commission to take action, under this 
                paragraph shall not at any time bar any proceeding or 
                any action with respect to any agreement between a 
                subsection (k) applicant and the reference product 
                sponsor, or any agreement between subsection (k) 
                applicants, under any other provision of law, nor shall 
                any filing under this paragraph constitute or create a 
                presumption of any violation of any competition 
                laws.''.
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