Congress Must Improve “No Generics” Proposal for Biologics

Healthcare Reform Offers Only the Illusion of Generic Competition for Biotech Drugs: Patient Access To Expensive New Medicines at Stake

U.S. Congress is considering proposals to establish a process for regulatory approval of generic versions of biotech drugs (“biologics”). The Food and Drug Administration (FDA) approval process available for conventional pharmaceuticals does not apply to biologics, which are drugs engineered from human or animal cells using biotechnology. New and different procedures are required to demonstrate the safety and efficacy of comparable and interchangeable biologic pharmaceuticals (called “biosimilars” or “biogenerics”).

Proposals passed by the Senate and House health committees as part of healthcare reform in July 2009, however, will establish prolonged delays before permitting price-lowering generic competition. Even worse, they will facilitate brand-name companies’ ability to renew their monopolies, potentially keeping generic firms out of the market for biologics altogether and creating only the illusion of generic competition. Either result will torpedo the objective of healthcare cost containment so crucial to current reform efforts, and severely limit patient access to these important and exceptionally high-priced medicines for conditions like cancer, arthritis and diabetes.

The bottom line is this: Under these proposals, Medicare and other federal programs will find their budgets increasingly strained by growing biologic drug costs. Employers will continue to struggle to provide affordable health insurance to their employees. Americans with insurance will find it even more difficult to pay for their already sky-high prescription drug co-payments. And the uninsured may have to go without crucial lifesaving biologics.

For more information, download the .pdf version of the briefing note here: BiologicsBriefingNote28_Sept_09.pdf

Download a .rtf version of the briefing note here: BiologicsBriefingNote28_Sept_09.rtf

For more details about one of the most pressing issues in these proposals, the creation of almost indefinite monopolies through the evergreening of the data exclusivity monopoly, please see the fact sheet available here.