Promoting Innovation and Access to Life-Saving Medicine Act

referredUnited States· United States Congress· EN

Introduced

26 March 2009

Last action

26 March 2009 · Introduced

Status

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

26 March 2009
Introduced
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Source: IntroReferral
26 March 2009
Introduced
Introduced in Senate
Source: IntroReferral

Votes

No vote records are attached yet.

Versions

Introduced in Senate · 26 March 2009 · Download file

Documents

3 official files

Introduced in Senate (text)

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Introduced in Senate (text)
Introduced in Senate · EN · 26 March 2009
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Introduced in Senate (PDF)
Introduced in Senate · EN · 26 March 2009
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Introduced in Senate
summary · EN · 26 March 2009
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
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Related records

related to → Promoting Innovation and Access to Life-Saving Medicine Act

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/111th-congress/senate-bill/726
Open data entity: https://api.congress.gov/v3/bill/111/s/726
us · 111-s-726 · source updated 5 December 2025