To amend the Public Health Service Act to provide for the approval of similar biological products, and for other purposes.
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.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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