The Public Policy

Generic Safety Risks

Generic copies of biologic drugs are a more complicated matter than generic copies of simple chemical compounds. Consequently, they should require more extensive testing. But does the Senate know that?

By 7.25.07

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The Senate Health Committee recently cleared a bill that would allow generic drug manufacturers to enter the multi-billion dollar biological-drug market. The measure, which next heads to the full Senate for a vote, would clear the way for these drugs by requiring the Food and Drug Administration to create an approval process for follow-on biologics.

Supporters of the legislation assert that its passage would save consumers billions of dollars and provide safe, affordable access to biologic drugs. These claims are severely overstated, however, and worrying safety issues are inherent in the bill's provisions.

Most drugs are formed from simple chemical compounds with structures that are easily duplicated. Generic copies are therefore exactly the same as their brand-name counterparts and are cheap to produce. But there's no such thing as a "generic" biologic, because they're much larger -- and much more complicated -- than simple chemical compounds.

Biologic production involves the use of life forms such as yeast and bacteria. Because of the diverse composition and metabolism of the producers, each final biologic product is a unique, heterogeneous mix of materials.

Consequently, safety review is very expensive -- and inexact without extensive clinical testing. Whereas common generics like penicillin only require 50-60 safety and quality manufacturing tests, biologics require at least four times that number. In fact, the technology is not yet available to map out the exact nature of one large biologic versus another.

Therefore, the cost-savings for follow-on biologics are limited. In the European Union and Australia, which both have regulatory systems for follow-on biologics, savings amount to roughly 10 percent off brand-name prices.

More important, the EU and Australia have had to devote a great deal of attention to safety. Unlike chemical generics, all biologics must address the reaction of the body's immune system to the drug. Failure to take this factor into account can result in devastating side effects.

Seven years ago in Europe, for example, a fully-tested biologic which aids in the production of red blood cells was found to have induced patients to experience "pure red cell aplasia," whereby their bodies could not make red cells. Many died.

Even after more than seven years of intense investigation, it is still unclear how the reaction happened. In response, the European Union created a rigorous regulatory system to review follow-on biologics.

Yet the follow-on biologics proposal that has cleared the Health Committee ignores these lessons. As written, it would allow the approval of follow-ons without the assessments required in the European Union, which include one year of testing, risk-management plans, and comparative clinical trials.

Further, the proposal legally allows molecular differences in follow-on products, even though such differences are the very ones scientifically shown to be associated with dangerous reactions.

A better way to guarantee safety -- while still improving access -- would be to test biologics as the Europeans have done. To help the underserved, Congress could also mandate that both branded and follow-on biologic firms participate in a low-cost or no-cost drug program for the needy.

With the measure makes its way to a full Senate vote, let's hope the nation's lawmakers put patient safety first in the debate over follow-on biologics.

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About the Author

Bryan A. Liang is executive director of the Institute of Health Law Studies at California Western School of Law; the co-director of the San Diego Center for Patient Safety at UCSD School of Medicine; and a member of the Center for Public Health Security at San Diego State University.