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Error processing SSI file

2009-S726 on Mar 11, 2009

Source: S.726&HR.1427
    Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products.
  • 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).
    1. Requires the Secretary to:
    2. 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
    3. establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.
  • Allows an applicant 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.

  • Topic: Health Care
  • Headline: Expedited licensing for biosimilar products
  • Headline 2: Sponsored bill expediting licensing for biosimilar products

  • Key for participation codes:
  • Sponsorships: p=sponsored; o=co-sponsored; s=signed
  • Memberships: c=chair; m=member; e=endorsed; f=profiled; s=scored
  • Resolutions: i=introduced; w=wrote; a=adopted
  • Cases: w=wrote; j=joined; d=dissented; c=concurred
  • Surveys: '+' supports; '-' opposes.

Democrats participating in 2009-S726

Michael Arcuri s1sNew York Democrat (until 2010)
Jeff Bingaman s1sNM Democratic Sr Senator (Retiring)
Sherrod Brown s1sOH Democratic Sr Senator
Lois Capps s1sCalifornia Democrat
John Conyers s1sMichigan Democrat
Raul Grijalva s1sArizona Democrat
Jim Himes s1sConnecticut Democrat
Blanche Lambert Lincoln s1sAR Former Democratic Senator
Bill Nelson s1sFL Democratic Sr Senator
Frank Pallone s1sNew Jersey Democrat
John Sarbanes s1sMaryland Democrat
Jan Schakowsky s1sIllinois Democrat
Charles Schumer s2pNY Democratic Sr Senator
Jeanne Shaheen s1sNH Democratic Sr Senator
Debbie Stabenow s1sMI Democratic Jr Senator
Henry Waxman s2pCalifornia Democrat

Republicans participating in 2009-S726

Susan Collins s1sME Republican Jr Senator
Nathan Deal s1sGA Republican Governor
Jo Ann Emerson s1sMissouri Republican
Jack Kingston s1sGeorgia Republican
Ron Paul s1sPOTUS Republican (Libertarian 1988)
Mac Thornberry s1sTexas Republican
David Vitter s1sLA Republican Jr Senator; previously Representative
Frank Wolf s1sVirginia Republican

Independents participating in 2009-S726

John Linder s1sGeorgia Former GOP (until 2010)
Mel Martinez s1sFL Former GOP Senator (resigned 2009); previously HUD Secy.

Total recorded by OnTheIssues:

Democrats: 16
Republicans: 8
Independents: 2

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