A bill to amend the Public Health Service Act to provide for the approval of biosimilars, and for other purposes.
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.
Introduced in Senate
Sponsor introductory remarks on measure. (CR S6867)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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