S 1505 · 110th Congress · Health
Affordable Biologics for Consumers Act
Bill Progress
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Introduced2
Committee3
Senate Vote4
House5
EnactedLatest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2007-05-24)
Plain Language Summary
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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 tha…
Summarized by Claude AI · Non-partisan · For informational purposes only