3.0.0 8190 2023-01-11T13:45:01Z 2023-01-11T13:45:01Z House HR 2020-09-08 116 [Congressional Record Volume 166, Number 154 (Tuesday, September 8, 2020)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GROTHMAN:H.R. 8190.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the Constitution of the UnitedStates[Page H4331]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2020-09-08T13:30:05Z 2020-09-16 Sponsor introductory remarks on measure. (CR H4487) IntroReferral B00100 9 Library of Congress 2020-09-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2020-09-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2020-09-08 Introduced in House IntroReferral 1000 9 Library of Congress G000576 Rep. Grothman, Glenn [R-WI-6] Glenn Grothman R WI 6 N S001204 Del. San Nicolas, Michael F. Q. [D-GU-At Large] Michael San Nicolas D GU F. Q. 0 2020-11-17 False Health Blood and blood diseases Competition and antitrust Drug safety, medical device, and laboratory regulation Drug therapy Health technology, devices, supplies Intellectual property Licensing and registrations Prescription drugs Health 00 2020-09-08 Introduced in House 2021-08-07T23:40:06Z Biosimilar Insulin Access Act of 2020

This bill establishes that, if the Food and Drug Administration (FDA) finds that an insulin is biosimilar to a reference product, the insulin shall be deemed interchangeable with the reference product. (A biological product is biosimilar to a reference product if the two products are highly similar and have no clinically meaningful differences; the reference product generally receives FDA approval first, but the biosimilar product is typically less expensive.)

Under current law, a biological product that is biosimilar to a reference product may be deemed interchangeable with the reference product only if it meets additional requirements. Current law provides that interchangeable products may be substituted for each other without the prescriber's involvement.

]]> Biosimilar Insulin Access Act of 2020 Display Title Biosimilar Insulin Access Act of 2020 Short Title(s) as Introduced Biosimilar Insulin Access Act of 2020 Introduced in House IH Official Title as Introduced To amend the Public Health Service Act to deem any insulin that is determined by the Secretary to be biosimilar to the reference product to be interchangeable with the reference product, and for other purposes. Introduced in House IH Introduced in House 2020-09-08T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr8190ih/xml/BILLS-116hr8190ih.xml 2020-09-16 Sponsor introductory remarks on measure. (CR H4487) 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.