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HR 1956 110th Congress House

Patient Protection and Innovative Biologic Medicines Act of 2007

Official title: To amend the Public Health Service Act to provide for the approval of similar biological products, and for other purposes.

Introduced: April 29, 2008 See on congress.gov
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This bill died when the 110th Congress ended
It never became law before the 110th Congress (2007–2008) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 20, 2007
Referred to the Subcommittee on Health.
Apr 19, 2007
Referred to the House Committee on Energy and Commerce.
Apr 19, 2007
Introduced in House
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 Latest action April 20, 2007

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.

Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.

Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.

Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.

Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.

Requires the Secretary to establish a Similar Biological Products Advisory Committee.

Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 1956: Patient Protection and Innovative Biologic Medicines Act of 2007. 110th Congress. Open America. https://openamerica.io/bill/110-HR-1956/
MLA
"H.R. 1956: Patient Protection and Innovative Biologic Medicines Act of 2007." 110th Congress, 2026, Open America, https://openamerica.io/bill/110-HR-1956/.
Bluebook (legal)
H.R. 1956, 110th Cong. (2026), https://openamerica.io/bill/110-HR-1956/.
Markdown link
[H.R. 1956: Patient Protection and Innovative Biologic Medicines Act of 2007](https://openamerica.io/bill/110-HR-1956/)
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