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.

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.


... morehide bill summary

Sponsor

• Sen. Edward Kennedy [D, MA]
• and 4 Co-Sponsors
  • Sen. Hillary Clinton [D, NY]
  • Sen. Michael Enzi [R, WY]
  • Sen. Orrin Hatch [R, UT]
  • Sen. Charles Schumer [D, NY]
  close

Committees

• Senate Health, Education, Labor, and Pensions

Amendments

This bill has no amendments.

Amendments to S.1695

Number	Status	Purpose

Bill Status

Make a Bill Status Widget

	OpenCongress widgets allow you to display information about bills and issue areas on your own website or blog. First, select which bill or issue you want to track, then customize the appearance of the panel, and finally paste a simple chunk of HTML into your site. Now your community will have an easy, up-to-date way to track the status of important bills and issues in Congress.

Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
June 26, 2007

Show All Actions (7 actions)Hide Actions

All Bill Actions

• Nov 19, 2008: Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. Without written report.
• Added to calendar on Nov 19, 2008: Placed on Senate Legislative Calendar under General Orders. Calendar No. 1127..
• Jun 27, 2007: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
• Added to calendar on Jun 27, 2007: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably..
• Jun 27, 2007: Committee on Health, Education, Labor, and Pensions. Date of scheduled consideration. S-211. 11:00 a.m.
• Jun 26, 2007: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
• Introduced on Jun 26, 2007.

---

Related Issue Areas:

• Medicine
• Budgets
• Business
• Drug approvals
• 8 more
• Drug industry
• Government trust funds
• Intellectual property
• Law
• Licenses
• Medical care
• Patent infringement
• User charges

Data from the Congressional Research Service

Show More User Statistics... Hide User Statistics

In the News

June 28, 2007 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 ...

Was this article useful? Yes or No

Source: FDA news (subscription), VA

Did you find this article useful? Your opinion counts - together, we're finding the very best news and blog coverage about Congress available on the web.

June 27, 2007 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. ...

Was this article useful? Yes or No

Source: Congressional Quarterly, DC

Did you find this article useful? Your opinion counts - together, we're finding the very best news and blog coverage about Congress available on the web.

See most useful news articles

Information made available by:

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 ...

Was this article useful? Yes or No

Source: Patent Docs

Did you find this article useful? Your opinion counts - together, we're finding the very best news and blog coverage about Congress available on the web.

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 ...

Was this article useful? Yes or No

Source: Patent Docs

Did you find this article useful? Your opinion counts - together, we're finding the very best news and blog coverage about Congress available on the web.

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

Ted Kennedy’s S.1695, Sen. Judd Gregg’s S.1505 and Rep. 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 manda

Was this article useful? Yes or No

Source: GoozNews

Did you find this article useful? Your opinion counts - together, we're finding the very best news and blog coverage about Congress available on the web.

47 more posts...
See most useful blog posts

Information made available by: