S.1505: A bill to amend the Public Health Service Act to provide for the approval of biosimilars, and for other purposes.

A bill to amend the Public Health Service Act to provide for the approval of biosimilars, and for other purposes. 5/24/2007--Introduced. 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 [...]

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