Archives
Buy photos
Contact the Globe
Globextra
Globe services
Search the Globe
Send us feedback
 

Cars, trucks, SUVs
Jobs (BostonWorks)
MarketBasket
Real Estate

AT ISSUE - BIOTECHNOLOGY

Caution is key in move toward genetic biologics

By Eileen Smith Ewing, 9/8/2002

he debate about creating a generic biotechnology industry keeps cropping up in odd places. Last month, in an effort to address the health care crisis, the Senate passed a bill that, among other things, lowered the hurdles for marketing and selling generic drugs. At the 11th hour, an amendment was introduced to expand the bill's purview from the pharmaceutical industry to the biotechnology industry - from drugs to biologics. The amendment failed, but the debate it engendered is unlikely to fade quietly.

''Biologics'' are the work product of the biotechnology industry. Like drugs, biologics may be used therapeutically to treat human disease. Unlike drugs, which are synthesized chemically, biologics are derived from living sources - humans, animals, or microorganisms. Biologics include those proteins and antibodies on the cutting edge of medical knowledge that are more likely to be administered by needle than by pill. Some of the biologics most familiar to us are human insulin and human growth hormone.

The first biologics were patented in the United States some 20 years ago. Over the next four years, about 18 of those early biotechnology products - representing over $10 billion in annual sales - will come off patent and lose market exclusivity. It is inevitable that Congress will have to consider whether generic versions of off-patent biologics should be permitted.

Certainly, the availability of generics benefits consumers. Once the patent for a drug expires, the introduction of generic versions of the same medicine increases competition and drives consumer prices down.

When it comes to generic biologics, however, Congress thus far has been appropriately cautious. The biotechnology industry has warned of the inherent difficulties of establishing the ''bioequivalence'' of generics to brand-name biologics. Biologics are harvested from highly specific cell lines; generic versions, coming from separately developed cell lines, may not in fact represent the same product. Pills, by contrast, are mixed from a recipe. It is a lot easier to be sure of baking substantially identical chocolate cakes than of breeding substantially identical microorganisms.

Patient safety may be an issue. For example, a tiny change in the production process of the Salk vaccine in the 1950s caused the form of vaccine used in manufacturing to remain active, and people then caught polio from the vaccine. More recently, a minor deviation in the method by which the human growth hormone was manufactured led to serious allergic reactions until the deviation was identified. It would be the job of the Food and Drug Administration to determine bioequivalence before approving generic versions of biologics - a task neither the current law nor the current agency structure accommodates.

Nonetheless, laws can be changed. Agency budgets can be expanded. Technological advances may make reliable testing of bioequivalence between brand-name products and generics more possible than in the early days of biotech. Rapid advances in bioinformatics, as well as in microarray technology and pharmacogenomics, may support that effort.

The question is not whether a generic biotechnology industry should ever be permitted, but rather whether this is the appropriate time to do so. With fewer than 20 biologics due to come off patent within the next four years - many of them relating to diseases affecting a small percentage of the population - one must question whether consumers would experience any significant near-term economic benefit from such a drastic change. In the near future the effect would not compare with the economic benefit offered by generic pharmaceuticals.

On the other hand, at a time when regions of the country dependent on high technology - notably New England - are relying on the economic promise of the biotechnology engine, this may not be the moment to step on the brakes. The development of new biologics is a process that craves massive amounts of investment capital over long periods. Venture capital investment in the life sciences has increased by double-digit percentages over the last couple of years, even while investment in other technology sectors has dropped precipitously. But investors are notoriously skittish. They are less likely to invest dollars for decades in a highly risky product if new legislation threatens to rob that product of market exclusivity, should it ever reach the market.

Skittish investors mean fewer biotechnology products under development - fewer biomedical breakthroughs that reach the consumer. Now, that's a health care problem.

Eileen Smith Ewing is a partner in the Boston office of Kirkpatrick & Lockhart LLP. She leads its nationwide Life Sciences group.

This story ran on page G4 of the Boston Globe on 9/8/2002.
© Copyright 2002 Globe Newspaper Company.