3.0.0 2011 2022-11-01T18:47:25Z 2022-11-01T18:47:25Z House HR 2019-04-01 116 [Congressional Record Volume 165, Number 56 (Monday, April 1, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeGETTE:H.R. 2011.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3--Commerce Clause[Page H2939]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-04-02T18:52:40Z Referred to 2019-04-01T16:02:40Z Protecting Access to Biosimilars Act of 2019 116 1140 S 2019-04-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Lower Health Care Costs Act 116 1895 S 2019-07-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. Related bill CRS 2019-04-02 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-04-01 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-04-01 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-04-01 Introduced in House IntroReferral 1000 9 Library of Congress D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 N R000585 Rep. Reed, Tom [R-NY-23] Tom Reed R NY 23 2019-04-01 True S001216 Rep. Schrier, Kim [D-WA-8] Kim Schrier D WA 8 2019-04-01 True G000558 Rep. Guthrie, Brett [R-KY-2] Brett Guthrie R KY 2 2019-04-01 True G000576 Rep. Grothman, Glenn [R-WI-6] Glenn Grothman R WI 6 2019-05-22 False C001120 Rep. Crenshaw, Dan [R-TX-2] Dan Crenshaw R TX 2 2019-06-27 False Health Allergies Blood and blood diseases Drug safety, medical device, and laboratory regulation Health promotion and preventive care Health technology, devices, supplies Immunology and vaccination Licensing and registrations Health 00 2019-04-01 Introduced in House 2021-09-02T13:57:11Z Protecting Access to Biosimilars Act of 2019

This bill excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)

]]> Protecting Access to Biosimilars Act of 2019 Display Title Protecting Access to Biosimilars Act of 2019 Official Title as Introduced To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009. Introduced in House IH Short Title(s) as Introduced Protecting Access to Biosimilars Act of 2019 Introduced in House IH Introduced in House 2019-04-01T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2011ih/xml/BILLS-116hr2011ih.xml 2019-04-02 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.