3.0.0 726 2023-01-11T13:19:40Z 2023-01-11T13:19:40Z Senate S S 2009-03-26 111 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2009-03-26T20:19:17Z Promoting Innovation and Access to Life-Saving Medicine Act 111 1427 HR 2009-03-12 Referred to the Subcommittee on Health. Identical bill CRS 2009-03-26 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2009-03-26 Introduced in Senate IntroReferral 10000 9 Library of Congress S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2009-03-26 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2009-03-26 True V000127 Sen. Vitter, David [R-LA] David Vitter R LA 2009-03-26 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2009-03-26 True M001162 Sen. Martinez, Mel [R-FL] Mel Martinez R FL 2009-03-26 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2009-03-26 True B000468 Sen. Bingaman, Jeff [D-NM] JESSE BINGAMAN D NM FRANCIS 2009-05-18 False L000035 Sen. Lincoln, Blanche L. [D-AR] BLANCHE LINCOLN D AR LAMBERT 2009-07-22 False N000032 Sen. Nelson, Bill [D-FL] CLARENCE NELSON D FL WILLIAM 2009-08-06 False Health Administrative remedies Child health Civil actions and liability Department of Health and Human Services Drug safety, medical device, and laboratory regulation Intellectual property Judicial procedure and administration Licensing and registrations Medical research Health 00 2009-03-26 Introduced in Senate 2009-05-01T15:55:41Z Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act.

Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product).

Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.

Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period.

Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes.

Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

]]> Promoting Innovation and Access to Life-Saving Medicine Act Display Title Promoting Innovation and Access to Life-Saving Medicine Act Official Title as Introduced A bill to amend the Public Health Service Act to provide for the licensing of biosimilar and biogeneric biological products, and for other purposes. Introduced in Senate IS Short Titles as Introduced Promoting Innovation and Access to Life-Saving Medicine Act Introduced in Senate 2009-03-26T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s726is/xml/BILLS-111s726is.xml 2009-03-26 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.