Patient Protection and Innovative Biologic Medicines Act of 2007

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 19 April 2007

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• Introduced in House (PDF)

  Introduced in House · EN · 19 April 2007

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• Introduced in House

  summary · EN · 19 April 2007

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