HR 1956 · 110th Congress · Health
Patient Protection and Innovative Biologic Medicines Act of 2007
Bill Progress
✓
Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2007-04-20)
Plain Language Summary
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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 guida…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (20)
19 Democrats1 Republican