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  • Working the Bugs Out of Biologics: A Look at the Access to Life-Saving Medicines Act and Follow-On Biologics

    This paper discusses The Access to Life Saving Medicines Act (Waxman-Schumer Act) introduced by Senator Clinton, Senator
    Schumer, and Representative Waxman, and how it seeks to solve the problems of approving follow-on biologics. Patients suffering from cancer, AIDS, and other chronic diseases are those that will be most affected by the bill, along with those states that foot the bill for prescription drug programs like Medicaid. In an effort to relieve some of this burden, the Waxman-Schumer Act seeks to amend the Public Health Services Act much in the same way that the Hatch-Waxman Act amended the Food Drug and Cosmetics Act in 1984, providing for an abbreviated process for traditional generic drugs. Not enough was known about biologics at the time to include them in the Hatch-Waxman Act, and biologics are still subject to a “de facto” patent extension due to the lag for FDA approval of generic biologic drugs.
    The Waxman-Schumer Act attempts to address the complexity of biologics and proof of equivalency to a branded biologic by
    focusing on therapeutic effect and manufacturing similarities. The questions are whether this approval process actually saves patients and prescription drug providers money, and whether that minimal savings is worth the abbreviation of safety and efficacy of a complex compound like a biologic. This paper answers in the affirmative and addresses the world market implications of having waited so long to take action in approval of follow-on biologics as well as standards currently in place in the industry to alleviate the burden of proving therapeutic similarity. Part II of this paper addresses the legal framework for existing follow-on drugs as well as the prospective framework for followon biologics. Part III discusses the science behind the follow-on drugs and the differences between traditional chemical drugs and biologics, as well as recommendations for ensuring safety of follow-on biologics. Finally, Part IV addresses the economics of delayed U.S. action in providing a framework for an abbreviated approval process along with international perspectives.