PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Health.
Congressional Research Service
Version 00 · Introduced in House · Apr 19, 2007
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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Inslee, Jay [D-WA-1] · D–WA
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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