Teva’s entry into the hepatitis C market (see yesterday’s post) comes at a time of increased attention to the uncharted path to regulatory approval for generic versions of biologics – drugs made from living organisms (i.e., cells), such as interferon.
Biologics often require injection, and are typically several times more expensive than other types of drugs made solely from chemicals. Several biologics cost well over a thousand dollars a month for a course of treatment; at the high end, Imclone's Erbitux (used for colon cancer) can cost $20,000 a month. Biologics make up a rapidly growing proportion of drug costs, and have spurred debate among cancer doctors over whether the costs of these treatments exceeds the benefits to patients. While the expense of biologics in part reflects their higher manufacturing costs, the lack of competition ensures that companies can price their drugs as high as the market will bear. The call for generic biologics reflects these skyrocketing prices and pressures on insurers, government payers, and patients.
The FDA has claimed that it cannot approve any generic (or, to use their term, “follow-on”) biologic products until there’s more clarity on legal and scientific issues. The legal issues hinge on whether the FDA currently has regulatory authority to approve generic biologics under the 505(b)(2) provision of the Hatch-Waxman amendment to the Federal Food, Drug and Cosmetic Act. The 1984 legislation (formally known as the Drug Price Competition and Patent Term Restoration Act) established a new and simplified regulatory framework to guide the approval of generic versions of original (“brand-name” or “innovator”) drugs.
In short, generic versions no longer had to duplicate the results of clinical trials (studies that test a drug’s safety and efficacy in patients) that were conducted for the approval of the original drug. Generic companies simply had to demonstrate “bioequivalence” – that the generic drug behaved the same way in the body as the original drug. The theory was that the active chemical ingredient was identical, so safety and efficacy should be the same as long as the drugs were bioequivalent (for more background on Hatch-Waxman, and its effect on competition and pricing, see this 1998 report from the Congressional Budget Office [PDF version]).
However, this bioequivalence model has not been tested for biologics, where the same “active chemical” (which in this case could be a protein such as interferon or antibodies, or genetic material – e.g., RNA or DNA) could in theory behave differently in the body depending on how it’s manufactured.
Sandoz, the generics division of Novartis, recently forced the question by submitting Omnitrop, a generic version of human growth hormone (somatropin), for approval in Europe and the United States. Omnitrop would compete with brand-name versions of human growth hormone from Serono and Genentech.
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