We’re all familiar with generic drugs, and they’ve been available in the U.S. for a long time now. However, there is a distinction that many aren’t aware of, and it hinges on the definition of chemical vs. biological drugs. The FDA has the authority to approve generic drugs that are based on chemical combinations, but does not have that same authority when it comes to drugs that are developed through biological processes.
Biogenerics have been available in other countries, particularly Europe, for some time, and under the new health care law, the FDA will now be able to approve biogenerics for sale in the U.S. That’s good news for Chicagoland companies like Lake Forest-based Hospira Inc. (which already sells biogenerics in Europe), and Therapeutic Proteins Inc., which is relocating from Deerfield to Chicago. It should also be good news for consumers, to the tune of billions of dollars annually. Of course, when compared to recently-revealed projections from the Centers for Medicare and Medicaid Services that predict health care costs rising by hundreds of billions of dollars under the new law, the savings from biogenerics is a relative paramecium.
Still, it’s progress, and we’ll take it. As long as nobody from Lehman Brothers gets involved. :)