3.0.0 1505 2023-01-11T16:47:38Z 2023-01-11T16:47:38Z Senate S S 2007-05-24 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-05-24T22:01:09Z 2007-05-24 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-05-24 Sponsor introductory remarks on measure. (CR S6867) IntroReferral B00100 9 Library of Congress 2007-05-24 Introduced in Senate IntroReferral 10000 9 Library of Congress G000445 Sen. Gregg, Judd [R-NH] Judd Gregg R NH N B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze 2007-05-24 True C000560 Sen. Coburn, Tom [R-OK] TOM COBURN R OK 2007-05-24 True Health Biotechnology Commerce Department of Health and Human Services Drug adulteration Drug approvals Drugs Executive reorganization Federal advisory bodies Government Operations and Politics Intellectual property Labeling Patents Science, Technology, Communications Health 00 2007-05-24 Introduced in Senate 2007-11-19T14:32:38Z Affordable Biologics for Consumers Act - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biosimilar, which is defined as a biological product that is claimed to be similar to a qualified biological product (the reference product). Defines a "qualified biological product" as a biotechnology-derived therapeutic biological or protein product licensed or approved under the Federal Food, Drug, and Cosmetic Act.

Allows the Secretary of Health and Human Services to approve an application for a biosimilar only: (1) for indications for which the reference product is approved; and (2) if the application conforms to the applicable final product class-specific rule and the Secretary concludes that the product is safe, pure, and potent.

Authorizes a person to request the issuance of a product class-specific rule applicable to a qualified biological product and its class.

Requires the Secretary to establish a Biosimilars Advisory Committee.

Prohibits the approval of a biosimilar until at least 14 years have elapsed from approval of the reference product.

Prohibits the Secretary from: (1) approving a product that is claimed to be similar to or the same as a reference product under any other provision of law; (2) approving another biosimilar for one year after approving the first biosimilar that relies on the same reference product; and (3) designating a biosimilar as interchangeable with (or therapeutically equivalent to) the applicable reference product.

Sets forth provisions related to patents for a reference product. Allows approval of an application for a biosimilar to be effective even if patent litigation has not concluded.

Amends the Federal Food, Drug, and Cosmetic Act to deem as misbranded a biotechnology-derived therapeutic protein if its labeling fails to meet specified requirements.

]]> Affordable Biologics for Consumers Act Display Title Affordable Biologics for Consumers Act Official Title as Introduced A bill to amend the Public Health Service Act to provide for the approval of biosimilars, and for other purposes. Introduced in Senate IS Short Titles as Introduced Affordable Biologics for Consumers Act Introduced in Senate 2007-05-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s1505is/xml/BILLS-110s1505is.xml 2007-05-24 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.