As part of $3K in 3 Weeks, here is another in a series of articles on current issues and topics related to Crohn’s disease and ulcerative colitis.
Did you know that biologics1 such as Remicade, Humira, and Cimzia – used in the treatment of Crohn’s disease and ulcerative colitis – are governed by different rules and laws than other traditional medications? As a result, there currently are no approved generic biologics in the U.S. So while you might be able to buy a generic version of a brand name pain killer or blood pressure medication, you can’t buy generic Remicade (at least not legally).
Why are generic biologics not available, and is that likely to change?
To answer those questions, we need to start with a quick history lesson: The generic drug industry arose in 1984 when the Hatch-Waxman Act made it much easier (and much less expensive) for qualified companies to produce a molecularly identical version of a drug after its patent had expired. (Prior to Hatch-Waxman, a company wishing to manufacture a generic drug would have had to repeat the full – and costly – clinical studies and the same FDA approval process that the original manufacturer went through.) Read the rest of this entry »
- Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combination of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. — Source: U.S. Food and Drug Administration [↩]
