Pathway for Biosimilars Act

To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.

3/13/2008--Introduced.
Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).
Requires the Secretary of Health and Human Services to approve the application if:
(1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and
(2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.
Prohibits a biological product from being evaluated against more than one reference product.
Prohibits licensure under this Act of a biological product containing specified agents or toxins.
Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.
Provides for confidentiality of information received pursuant to this Act.
Sets forth provisions governing patent infringement actions related to this Act.
Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.


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Sponsor

• Rep. Anna Eshoo [D, CA-14]
• and 43 Co-Sponsors
  • Rep. Joe Barton [R, TX-6]
  • Rep. Brian Bilbray [R, CA-50]
  • Rep. Frederick Boucher [D, VA-9]
  • Rep. Robert Brady [D, PA-1]
  • Rep. Stephen Buyer [R, IN-4]
  • Rep. Michael Capuano [D, MA-8]
  • Rep. Christopher Carney [D, PA-10]
  • Rep. André Carson [D, IN-7]
  • Rep. Susan Davis [D, CA-53]
  • Rep. William Delahunt [D, MA-10]
  • Rep. Charles Dent [R, PA-15]
  • Rep. Joe Donnelly [D, IN-2]
  • Rep. Brad Ellsworth [D, IN-8]
  • Rep. Chaka Fattah [D, PA-2]
  • Michael Ferguson
  • Rep. Jim Gerlach [R, PA-6]
  • Rep. Walter Herger [R, CA-2]
  • Rep. Baron Hill [D, IN-9]
  • Rep. Tim Holden [D, PA-17]
  • Rep. Rush Holt [D, NJ-12]
  • Rep. Michael Honda [D, CA-15]
  • Rep. Zoe Lofgren [D, CA-16]
  • Rep. Stephen Lynch [D, MA-9]
  • Rep. Kevin McCarthy [R, CA-22]
  • Rep. James McGovern [D, MA-3]
  • Rep. Patrick Murphy [D, PA-8]
  • Rep. Tim Murphy [R, PA-18]
  • Rep. Richard Neal [D, MA-2]
  • Rep. Devin Nunes [R, CA-21]
  • Rep. William Pascrell [D, NJ-8]
  • Rep. Mike Pence [R, IN-6]
  • Rep. Thomas Petri [R, WI-6]
  • Rep. Joseph Pitts [R, PA-16]
  • Rep. David Price [D, NC-4]
  • Rep. Michael Rogers [R, MI-8]
  • Rep. Loretta Sanchez [D, CA-47]
  • Rep. John Shimkus [R, IL-19]
  • Rep. Mark Souder [R, IN-3]
  • Rep. Clifford Stearns [R, FL-6]
  • Rep. C. Thompson [D, CA-1]
  • Rep. Frederick Upton [R, MI-6]
  • James Walsh
  • Albert Wynn
  close

Committees

• House Judiciary
• 3 more
  • House Energy and Commerce
  • House Judiciary
  • House Energy and Commerce
  close

Amendments

This bill has no amendments.

Amendments to H.R.5629

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
March 13, 2008

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All Bill Actions

• Apr 14, 2008: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
• Mar 13, 2008: Sponsor introductory remarks on measure. (CR E401-402)
• Introduced on Mar 13, 2008.
• Mar 13, 2008: Referred to House Energy and Commerce
• Mar 13, 2008: Referred to the Subcommittee on Health.
• Mar 13, 2008: Referred to House Judiciary
• Mar 13, 2008: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

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Related Issue Areas:

• Actions and defenses
• Administrative fees
• Administrative procedure
• Administrative remedies
• 25 more
• Budgets
• Child health
• Children
• Clinical trials
• Confidential communications
• Department of Health and Human Services
• Drug approvals
• Drugs
• Executive departments
• Food and Drug Administration (FDA)
• Government information
• Government publicity
• Hazardous substances
• Health policy
• Intellectual property
• Law
• Licenses
• Medical care
• Medical supplies
• Medicine
• Patent infringement
• Patents
• Pharmaceutical research
• Poisons
• Science policy

Data from the Congressional Research Service

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In the News

March 26, 2008 New US biosimilars bill a disappointing distraction, says GPhA

HR 5629, the bipartisan Pathway for Biosimilars Act introduced in the House by Representatives Anna Eshoo (Democrat, California) and Representative Joe ...

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Source: In-PharmaTechnologist.com, UK

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March 18, 2008 California Healthcare Institute Supports Introduction of ...

... March 14, to Congresswoman Anna Eshoo (D-Menlo Park) commending her for the introduction of HR 5629, the “Pathway for Biosimilars Act,” legislation that ...

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Source: Earthtimes, UK

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Blog Coverage

January 04, 2009 Patent Docs: Top Stories of 2008: #9 to #6

Five follow-on biologics bills were introduced during the 110th Congress: H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data ...

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Source: Patent Docs

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January 02, 2009 Patent Docs: Teva CEO Predicts Passage of Follow-on Biologics Bill ...

We also reported last summer that the Biotechnology Industry Organization (BIO) indicated that either H.R. 1956 (providing fourteen years of exclusivity), H.R. 5629 (providing twelve years of exclusivity), or S. 1695 (also providing ...

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Source: Patent Docs

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December 14, 2008 GoozNews: Biosimilars, Biogenerics Not the Same

Anna Eshoo’s H.R.5629 each call for testing drugs for safety, purity and “potency.” The FDA uses potency as a synonym for efficacy. In other words, all three bills would mandate clinical trial effectiveness testing – the expensive ...

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Source: GoozNews

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