Affordable Biologics for Consumers Act

Summary

Affordable Biologics for Consumers Act - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biosimilar, which is defined as a biological product that is claimed to be similar to a qualified biological product (the reference product). Defines a "qualified biological product" as a biotechnology-derived therapeutic biological or protein product licensed or approved under the Federal Food, Drug, and Cosmetic Act. Allows the Secretary of Health and Human Services to approve an application for a biosimilar only: (1) for indications for which the reference product is approved; and (2) if the application conforms to the applicable final product class-specific rule and the Secretary concludes that the product is safe, pure, and potent. Authorizes a person to request the issuance of a product class-specific rule applicable to a qualified biological product and its class. Requires the Secretary to establish a Biosimilars Advisory Committee. Prohibits the approval of a biosimilar until at least 14 years have elapsed from approval of the reference product. Prohibits the Secretary from: (1) approving a product that is claimed to be similar to or the same as a reference product under any other provision of law; (2) approving another biosimilar for one year after approving the first biosimilar that relies on the same reference product; and (3) designating a biosimilar as interchangeable with (or therapeutically equivalent to) the applicable reference product. Sets forth provisions related to patents for a reference product. Allows approval of an application for a biosimilar to be effective even if patent litigation has not concluded. Amends the Federal Food, Drug, and Cosmetic Act to deem as misbranded a biotechnology-derived therapeutic protein if its labeling fails to meet specified requirements.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 24 May 2007

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 24 May 2007

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• Introduced in Senate

  summary · EN · 24 May 2007

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