Prescription Drugs Special Report
The Wait for Generic Biologic Drugs
If you take insulin, Avastin, Remicade, or another biologic drug, you may have wondered why a less expensive generic version isn’t available for you. Our new report explains the hurdles drug companies face in creating a true bioequivalent to a brand-name biologic drug.
The health of many people with diabetes depends on taking insulin, a hormone produced naturally by the pancreas. For years, insulin for diabetes was extracted from the pancreases of pigs and cows. Then, in the early 1980s, the biotech revolution scored its first blockbuster product.
Scientists figured out how to take the gene for insulin from a human cell and insert it into bacteria, making it possible to produce human insulin in a laboratory in large quantities. Soon followed many other complex biotech drugs, or "biologics," which are genetically engineered and produced in living cells -- not only bacteria but also yeast and animal or human cells. In contrast, most traditional prescription drugs are made in a lab from chemicals.
High Price of Treatment -- Many biologic drugs have become widely used for a variety of diseases, including low white blood cell counts from cancer chemotherapy (pegfilgrastim [Neulasta]), arthritis (infliximab [Remicade]), anemia (epoetin alfa [Procrit, Epogen]), and previously untreatable conditions such as the metabolic disorder Gaucher's disease (imiglucerase [Cerezyme]). But these high-tech drugs also come at a high price, reflecting the large costs of developing and manufacturing them. Even with insurance, people must dip into their pockets for significant copays.
What is also keeping the costs high for consumers is that, in general, there are no generic versions available of these pricey biologic drugs. Generics, or copies of brand-name drugs, have helped keep down the costs of traditional, chemical-based prescription drugs for years. Once a patent for a traditional drug has expired, other companies are free to seek approval of a generic copy and then hope people buy it instead of the brand-name product.
Generic drugs are typically sold at a lower price than brand names because the generic company does not need to recover the costs of research and development, and this competition causes the price of the brand-name drug to drop as well. But when it comes to biologics, there is not yet a legal process for generic drug manufacturers to receive U.S. Food and Drug Administration (FDA) approval to market competing versions of brand-name biological drugs.
What’s the problem? With traditional chemical-based drugs, all a generic manufacturer needs to do is demonstrate that its chemical copy contains the same active ingredients, purity, and quality and is "bioequivalent" to the brand-name medication, meaning it produces a similar concentration of medication in the blood over time. Then it is assumed it will have the same effect in the body. The generic manufacturer need not do a whole new round of safety and effectiveness studies. Instead, it "piggybacks" onto existing data collected by the brand-name company.
But true bioequivalence between a biologic and its generic counterpart is impossible, according to industry groups like the Biotech Industry Organization. These groups argue that while conventional chemical drugs are usually small, simple molecules that are fairly easy to copy, biologics are much larger and more complex and therefore harder to copy. In their view, copying such a molecule is akin to making an exact replica of the Taj Mahal versus a simple ranch home.
What's more, the characteristics of the final drug product are heavily dependent on the complex process used to make them. For example, a slight genetic difference in the cells or bacteria used to make a generic biologic can result in a drug that might trigger an allergic response or something worse. And a small change in the production process could result in a less potent drug. In addition, because biologics are engineered from living cells, manufacturers must take greater care to prevent contamination by viruses or bacteria.
Posted in Prescription Drugs on December 29, 2009
