S.1695 - Biologics Price Competition and Innovation Act of 2007

A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. view all titles (2)

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  • Short: Biologics Price Competition and Innovation Act of 2007 as introduced.
  • Official: A bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. as introduced.

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  • Past Seven Days: 7
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Introduced
 
Senate
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House
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President
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06/25/07
 
 
 
 
 
 
 

Official Bill Text Comment on about 85 Pages

Official Summary

6/26/2007--Introduced.Biologics Price Competition and Innovation Act of 2007 - 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 th
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Official Summary

6/26/2007--Introduced.
Biologics Price Competition and Innovation Act of 2007 - 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 license the biological product if it is biosimilar to or interchangeable with the reference product. Allows a determination of interchangeability if the product is:
(1) biosimilar to the reference product and can be expected to produce the same clinical result in any given patient; and
(2) the risk in terms of safety or diminished efficacy of alternating or switching between the products is not greater than the risk of using the reference product without switching.
Prohibits the Secretary from determining that a second or subsequent biological product is interchangeable for any condition of use until one year after the first commercial marketing of the first product to be approved as interchangeable for that reference product.
Prohibits the Secretary from making approval of an application under this Act f effective until 12 years after the date on which the reference product was first licensed.
Authorizes the Secretary to issue product class-specific guidance.
Sets forth provisions governing patent infringement actions related to the exchange of confidential information, good faith negotiations, and the filing of an infringement action.
Requires the Secretary to:
(1) develop recommendations with respect to the goals for the process for the review of biosimilar biological product applications; and
(2) collect and evaluate data regarding the cost of reviewing such applications.


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Recent News Coverage

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06/27/07
Senate Committee Passes Follow-On Biologics Bill

The Biologics Price Competition and Innovation Act, S. 1695, allows the FDA to use its scientific discretion in approving products that are biosimilar to ...

Source: FDA news (subscription), VA
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06/26/07
Panel OKs Bill to Spur Generic Versions of Biotech Drugs

... amendments from both sides, preserving what they described as a delicate compromise on the legislation ( S 1695 ), which was approved by voice vote. ...

Source: Congressional Quarterly, DC
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Recent Blog Coverage

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09/22/09
S.1695: A bill to authorize the award of a ... - OpenCongress

Official government data, breaking news and blog coverage, public comments and user community for S.1695 A bill to authorize the award of a Congressional gold medal to the Montford Point Marines of World War II. ... Expresses the sense of Congress that the

Source: opencongress.org
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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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