Blog Articles for H.R.5629 feed

H.R.5629: To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.

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September 24, 2008 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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Source: Bio Pharma Bonanza


September 19, 2008 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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Source: All Articles on Martindale.com


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


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


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


June 04, 2008 WALSH CO-SPONSORS BILL TO PROTECT CONSUMERS AND FACILITATE ...

(Washington DC)- Congressman Jim Walsh today announced that he has co-sponsored legislation -- HR 5629, the Pathway for Biosimilars Act -- to hold biosimilars to the same Food and Drug Administration (FDA) approval standards as the ...

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Source: Press Releases


May 22, 2008 The Latest from Orange Book Blog

Patent Litigation Under a Future Biosimilars Act. Posted: 21 May 2008 08:17 PM CDT. Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. ...

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Source: allaboutviagraonline


May 20, 2008 Health News from Medical News Today (60 сообщений)

HSE Warns Employers To Assess Risks Properly After Worker Loses Finger In Unguarded Circular Saw, UK Employers are being warned, by the Health and Safety Executive (HSE), to ensure they assess workplace machinery risks properly to ...

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Source: Medici


May 20, 2008 Industry Group Letter Indicates Qualified Support For Bill To ...

The Biotechnology Industry Organization has issued a letter to Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) to indicate qualified support for a bill (HR 5629) that they have introduced to allow FDA to approve generic biotech ...

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Source: Men's & Drug's


April 11, 2008 Coalition Releases Letter In Support Of Follow-On Biologics

BIO has drafted its own letter supporting a follow-on biologics bill (HR 5629) proposed by Rep. Anna Eshoo (D-Calif.) and House Energy and Commerce ranking member Joe Barton (R-Texas). According to BIO’s draft letter, the legislation’s ...

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Source: Men's & Drug's


April 07, 2008 Proposed Bill Could Pave the Way for the Approval of Biogenerics

HR 5629 is a bipartisan bill called the Pathways for Biosimilars Act. This bill was introduced by Representatives Anna Eshoo (Democrat, California) and Joe Barton (Republican, Texas). This bill provides a way for biosimilars to be ...

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Source: Frost.com - Pharmaceuticals and Biotechnology...


March 19, 2008 Patent Docs

The bill (HR 5629), which would amend Section 351 of the Public Health Service Act to create a regulatory pathway for biosimilars, has been referred to the Committee on Energy. ...

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Source: Antibody Technologies


March 18, 2008 New Follow-on Biologics Bill Introduced in the House

... at right) introduced a new biologics bill in the House. The bill (HR 5629), which would amend Section 351 of the Public Health Service Act to create a regulatory pathway for biosimilars, has been referred to the Committee on Energy...

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Source: Patent Docs


March 17, 2008 GPhA opposes HR 5629, biologics bill

Generic Pharmaceutical Association issues statement on HR 5629 biologics bill.

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Source: Drug Topics - Drug Topics Daily News


March 16, 2008 Rep. Eshoo Formally Introduces “Pathway for Biosimilars Act ...

Last Friday, Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) announced the introduction of HR 5629, the “Pathway for Biosimilars Act.” We previously reported on a draft version of the bill circulated on Capitol Hill in February ...

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Source: FDA Law Blog


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