Healthcare costs are rising at about double the general inflation rate, and increases in drug prices have been even steeper. Congress is trying to control those prices with legislation that would allow for the manufacture of lower-cost generic, or follow-on copies, of biopharmaceuticals.
Since 1984, the marketing of generic drugs has been governed by the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act. By allowing approval of generic products through an abbreviated and less costly route than for innovator drugs, this legislation has given rise to a robust and valuable generic drug industry.
When Hatch-Waxman was conceived, biopharmaceuticals were new; now they are both common and expensive, accounting for some 13% of U.S. drug expenditures. To extend the benefits of Hatch-Waxman, Rep. Henry Waxman (D-CA) has introduced legislation designed to speed up the process by which follow-on versions of biopharmaceuticals can be marketed. Supporters of these efforts want generic drug producers to do for biopharmaceuticals what they currently do with traditional drugs. They believe that generic versions of biotech drugs should be approved for the market immediately after patents expire, with a minimum amount of testing.
Before Congress and FDA move too hastily to mandate follow-on copies of biopharmaceuticals, however, they need to consider that not all drugs are equal and not all efforts to drive down prices will be safe for patients.
Biopharmaceuticals are not like the traditional, small molecule pharmaceuticals that control pain, blood pressure, or high cholesterol. They are made in living cells. Biopharmaceuticals are larger and have more complex molecular structures than traditional, small molecule drugs. Recognizing this difference is critical to understanding that generic, or more accurately follow-on versions, cannot be regulated in the same way as small molecule generics.
Scientifically and medically, biopharmaceuticals and traditional drugs are not comparable. Because most conventional pharmaceuticals can be manufactured with easily replicable chemical processes, the clinical trial data that supported approval of the original version can be relied upon for the generic versions. The latter need only demonstrate bioequivalence to the original version by means of simple tests.
The production of biopharmaceuticals is far more complex. Protein folding, various kinds of enzymatic modifications, and impurities inevitably introduce variation, sometimes with unexpected results. Even minuscule differences in the substances that accompany or contaminate the active drug substance can be clinically significant, and because the same biopharmaceutical may be purified from widely differing substrates—bacteria, yeast, or cultured mammalian cells, for example—the contaminants may vary widely.