AAM White Paper: Ensuring the Future of Accessible Medicines in the U.S.

Patient health and well-being depends on the uninterrupted availability of lower-cost generic and biosimilar medicines. Moreover, as patients live longer the importance of a robust and sustainable generic and biosimilar medicines industry becomes only that much more important. Policymakers must act quickly to ensure continued saving and market-based competition, as well as prevent shortages, for future availability of affordable medicines. This requires:

• Enactment of the CREATES Act to prevent regulatory shenanigans;

• Scrutiny of patent gamesmanship to ensure that generics and biosimilars are able to launch at the earliest possible date;

• Continued regulatory attention to the review and approval of complex generics;

• Placement of biosimilar medicines on a level competitive playing field;

• Repeal or modification of the Medicaid Generics Penalty to prevent unintended harms;

• Focusing state drug pricing efforts on high-priced brand drugs that drive costs; and

• Increasing use of cost-saving generics for low-income patients in Medicare.

Altogether, these will ensure that generic and biosimilar medicines can enter new markets and that such markets are sustainable for the long-term.

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