3.0.0 6478 2023-01-11T13:41:58Z 2023-01-11T13:41:58Z House HR 2018-07-23 115 [Congressional Record Volume 164, Number 123 (Monday, July 23, 2018)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SARBANES:H.R. 6478.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the U.S. Constitution.____________________[Page H6650]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2018-07-27T17:39:49Z Referred to 2018-07-23T16:01:40Z 2018-07-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2018-07-23 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2018-07-23 Introduced in House IntroReferral Intro-H 9 Library of Congress 2018-07-23 Introduced in House IntroReferral 1000 9 Library of Congress S001168 Rep. Sarbanes, John P. [D-MD-3] John Sarbanes D MD P. 3 N J000292 Rep. Johnson, Bill [R-OH-6] Bill Johnson R OH 6 2018-07-23 True Health Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Contracts and agency Department of Justice Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Prescription drugs Health 00 2018-07-23 Introduced in House 2019-08-20T19:49:43Z 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.

]]> Biosimilars Competition Act of 2018 Display Title Biosimilars Competition Act of 2018 Official Title as Introduced 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. Introduced in House IH Short Titles as Introduced Biosimilars Competition Act of 2018 Introduced in House 2018-07-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr6478ih/xml/BILLS-115hr6478ih.xml 2018-07-27 Referred to the Subcommittee on Health. text/xml EN 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. Congressional Research Service, Library of Congress This file contains bill summaries and statuses 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.