H.R.5629 - 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. view all titles (2)

All Bill Titles

  • Short: Pathway for Biosimilars Act as introduced.
  • Official: To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes. as introduced.

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06/27/10
H.R.5629: Oil Spill Accountability and Environmental Protection ...

The same bill has been introduced in the United States Senate by Senator Charles Schumer (D-NY), and a competing bill, the “Pathways for Biosimilars Act” (HR 5629), has been introduced in the House by Representative Anna Eshoo (D-CA). ... Source: Rocck

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01/03/09
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 ...

Source: Patent Docs
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01/01/09
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 ...

Source: Patent Docs
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12/13/08
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 ...

Source: GoozNews
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12/09/08
More biopharmas lobby on biogenerics - FierceBiotech

Jay Inslee (D, WA) as well as H.R. 5629, the Pathway for Biosimilars Act, introduced by Reps. Anna Eshoo (D, CA) and Joe Barton (R, TX). BIO supports a pathway which protects patient safety and provides incentives for continued ...

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11/19/08
Economist Argues That 7 Years Ought to be Enough for Biologic Data ...

HR 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional two years for a new indication and six months for pediatric exclusivity. In contrast, recent legislation introduced ...

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11/19/08
Patent Baristas » Economist Argues That 7 Years Ought to be Enough ...

H.R. 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional two years for a new indication and six months for pediatric exclusivity. In contrast, recent legislation ...

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11/19/08
Economist Argues That 7 Years Ought to be Enough for Biologic Data ...

H.R. 5629, sponsored by Representatives Eshoo and Barton, would guarantee 12 years of data exclusivity, with an additional two years for a new indication and six months for pediatric exclusivity. In contrast, recent legislation ...

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11/09/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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10/14/08
UAEM Calls on AAU to Withdraw Endorsement of Eshoo-Barton Follow ...

Universities Allied for Essential Medicines (UAEM) today called on Robert M. Berdahl, President of the Association of American Universities (AAU), to withdraw its recent endorsement of HR 5629, the “Pathway for Biosimilars Acts,” which ...

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10/09/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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09/24/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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09/24/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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09/24/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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09/24/08
Study Promotes Hatch–Waxman Model for Biologics Exclusivity ...

... Act (HR 5629), introduced by Representative Anna Eshoo (D-CA) and Representative Joseph Barton (R-TX); The Patient Protection and Innovative Biologic Medicines Act of 2007 (HR1956), introduced by Representative Jay Inslee (D-WA). ...

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09/24/08
CQ Politics | Report: Increased Competition Will Produce Better ...

Anna G. Eshoo , D-Calif., introduced a measure ( HR 5629 ) that would allow for a period of data exclusivity of 14 years between innovator companies — firms that are developing new biologic drugs — and firms producing follow-on biologic ...

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09/23/08
Red or Blue: We’ll Likely to See Biosimilars Either Way

See also HR 5629: Pathway for Biosimilars Act. The legislation includes standards for the FDA to approve follow-on biologics as well as a period of exclusivity for the brand name drug company. The Act amends section 351 of the Public ...

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09/21/08
Waxman: FOBs Would Ensure Market Competition

Specifically, BIO has said it supports HR 5629, introduced into the House by Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas), which calls for up to 14.5 years of exclusivity for innovators; HR 1956, introduced by Jay Inslee (D-Wash ...

Source: HTA Blog
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09/18/08
CQ Politics | Less Is Better On Biologic Exclusivity, Candidates ...

Anna G. Eshoo , D-Calif., introduced a measure ( HR 5629 ) that would allow for a period of data exclusivity of 14 years, and is supported by the biotech industry. The Senate Health, Education, Labor and Pensions Committee has approved ...

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09/18/08
The Pathway for Biosimilars Act - Path or Detour?

With the introduction of the bipartisan Pathway for Biosimilars Act, HR 5629 introduced by Congresswoman Anna Eshoo (D-CA) and committee ranking member Joe Barton (R-TX), many questions have arisen as to whether this proposed ...

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09/16/08
Resolution Trust Corporation and Congress

H.R. 5629. Resolution Trust Corporation Asset Recovery Act of 1992. 102d Cong., 2d sess., July 21, 1992. U.S. Senate. S. 2155. Resolution Trust Corporation Reorganization Act. 101st Cong., 2d sess., February 21, 1990. ———. S. 3112. ...

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09/16/08
Report: Increased Competition Will Produce Better, Cheaper Follow ...

biologic drugs but none of those bills are expected to pass before Congress adjourns for the year. Rep. Anna G. Eshoo , D-Calif., introduced a measure (HR 5629) that would allow for a period of data exclusivity of 14 years between ...

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09/03/08
follow-on biologics (fobs)

two pieces of federal legislation involving fobs:. hr 1956 - inslee - “patient protection & innovative biologic medicines act of 2007″. hr 5629 - eshoo/barton - “pathway for biosimilars act”

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08/06/08
Virginia Biotechnology Association

Jay Inslee (D-WA) “The Patient Protection and Innovative Biologic Medicines Act of 2007,” and H.R. 5629, sponsored by Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX), “The Pathway for Biosimilars Act of 2008.” According to BIO, both of ..

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06/27/08
medworm query: cialis online (50 сообщений)

one bill (hr 5629) by rep. anna eshoo (d-calif.) would allow for a 14-year period of data exclusivity, while another bill (hr 1038) by rep. henry waxman (d-calif.) contains no exclusivity period (mccarthy, cq healthbeat, 6/26). ...

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06/26/08
CBO Savings Estimate for Follow-On Biologics, Biotechnology ...

H.R. 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007; H.R. 5629, the Pathway for Biosimilars Act; and S. 1695 all come close to striking this necessary balance. "Notably, the CBO study projects savings in-line ...

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06/25/08
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 ...

Source: Pharmalot
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06/18/08
House Commerce Committee Posts Responses to its Questions on ...

Anna Eshoo (D-CA), who is a member of the Subcommittee on Health, introduced the Pathway for Biosimilars Act (HR 5629). In February 2007, Rep. Henry Waxman (D-CA), who is also a member of the subcommittee, introduced the Access to ...

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06/14/08
[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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06/10/08
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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