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 30 Co-Sponsors
  • Rep. Joe Barton [R, TX-6]
  • Rep. Brian Bilbray [R, CA-50]
  • Rep. Frederick Boucher [D, VA-9]
  • Rep. Stephen Buyer [R, IN-4]
  • Rep. Michael Capuano [D, MA-8]
  • Rep. André Carson [D, IN-7]
  • Rep. William Delahunt [D, MA-10]
  • Rep. Michael Ferguson [R, NJ-7]
  • Rep. Baron Hill [D, IN-9]
  • Rep. Tim Holden [D, PA-17]
  • 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. Tim Murphy [R, PA-18]
  • Rep. Patrick Murphy [D, PA-8]
  • Rep. Richard Neal [D, MA-2]
  • Rep. Devin Nunes [R, CA-21]
  • Rep. Mike Pence [R, IN-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. C. Michael Thompson [D, CA-1]
  • Rep. Frederick Upton [R, MI-6]
  • Rep. James Walsh [R, NY-25]
  • Rep. Albert Wynn [D, MD-4]
  close

Committees

• House Judiciary
• 2 more
  • House Energy and Commerce
  • 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

Show All Actions (6 actions)Hide Actions

All Bill Actions

• Mar 13, 2008: Referred to House Judiciary
• Mar 13, 2008: Referred to the Subcommittee on Health.
• Mar 13, 2008: Referred to House Energy and Commerce
• 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.
• Mar 13, 2008: Sponsor introductory remarks on measure. (CR E401-402)
• Introduced on Mar 13, 2008.

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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

June 26, 2008 Biogenerics Would Save How Much?

The bills, by the way, are S. 1695, the Biologics Price Competition and Innovation Act of 2007; HR 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007; and HR 5629, the Pathway for Biosimilars Act. If you go to ...

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Source: Pharmalot

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June 15, 2008 [IHRO] Ariyan Invasion; The Indus Valley Decipherment Hoax ...

1 ((sup)*(/sup), HR 5629, ASI 63.10.371, HU 441; photographed by Erja Lahdenper. Courtesy ASI, Government of India. H-103a, Vol. 1 (*), 2789, ASI 63.11.116, HU 601; photographed by Erja Lahdenper. Courtesy ASI, Government of India. ...

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Source: Human Rights Movements

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June 11, 2008 Letter: Data Exclusivity a Necessity for Creation of New Biologics

Anna G. Eshoo, D-Calif., and Joe L. Barton, R-Texas, in support of the lawmakers’ legislation that would create an approval pathway for follow-on biologics (HR 5629). The letter highlights the bill’s proposed data exclusivity period as ...

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Source: CQ healthbeat News

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