<?xml version="1.0" encoding="UTF-8"?><BillSummaries>
<item congress="115" measure-type="hr" measure-number="6478" measure-id="id115hr6478" originChamber="HOUSE" orig-publish-date="2018-07-23" update-date="2019-08-20">
<title>Biosimilars Competition Act of 2018</title>
<summary summary-id="id115hr6478v00" currentChamber="HOUSE" update-date="2019-08-20">
<action-date>2018-07-23</action-date>
<action-desc>Introduced in House</action-desc>
<summary-text><![CDATA[<p><b>Biosimilars Competition Act of 2018</b></p> <p>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. </p> <p>Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already-approved biological product.</p>]]></summary-text>
</summary>
</item>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
<dc:contributor>Congressional Research Service, Library of Congress</dc:contributor>
<dc:description>This file contains bill summaries for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.</dc:description>
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</BillSummaries>
