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Biotech must work with the FDA to ensure the safety of biogenerics.

If recent moves by President George W. Bush and the FDA to speed traditional generic drugs to market are any indication—and they are—it�s clear that generic versions of brand-name biotech drugs, called biogenerics, are on their way (see “Ready or Not,” page 6 of the Journal, Issue 2).

Though the eventual outcome is almost certain, the steps that lead there are not. Granted, politicians and patient advocates pushing for biogenerics haven�t always appreciated the very real scientific challenges inherent in creating biologics. But biotech, in the form of its lobby the Biotechnology Industry Association, seems to think it can hold off the tide of biogenerics by engaging in nitpicking in the guise of safety concerns.

It�s true that the prevailing attitude toward licensing biogenerics must be one of caution. But at the same time, the scientific community needs to separate patent protectionism from real safety challenges.

The FDA allowed Biogen to move the manufacturing process for Avonex (interferon beta-IA) from one cell line and manufacturing facility to another when in vivo human data demonstrating equivalence was presented. Is it unreasonable to ask that the FDA, if it approved this kind of transfer, also allow the transfer of those manufacturing skills from one company to another?

Why not require that the original manufacturer of a biologic whose patent has expired make all the details of the manufacturing process available to those who wish to manufacture generic versions of the compound? Such companies could be compensated by a one-year extension of their patent protection, using the same principle that was applied in the Orphan Drug Act to encourage manufacturers to work for the public good.

This assumes that the process the FDA will require of generic biologic makers doesn�t require an expensive reapproval process. But this is an economic issue, not a regulatory one. Whether it�s practical or economically beneficial to produce generic biologics should have no bearing on the decision to make it legal to do so—in a manner that can best benefit health care consumers and manufacturers.



Chronic diseases and the reinvention of health care.

Bioethics: more rational, less political.

Mark McClellan brings new leadership to the FDA.

» Toward a plan to make safe generic versions of biologics.

By Invitation

Larry Brilliant