In 2005, insulin cost state Medicaid programs $500 million. The diabetes epidemic is causing the government to question one of the big-ticket items on the shopping list - insulin. Insulin was developed over 20 years ago and many of these original forms are now off patent. This is a screaming opportunity for generic drug makers to prosper and government programs to save.
Two of the largest insulin makers, Novo Nordisk and Eli Lily, say they are opposed to any F.D.A. action that would approve generic insulin without clinical studies. Why the concern? The combined sales in the United States for Humulin and Novolin is about $1 billion. No wonder.
A drug maker needs to prove the generic version contains the same active ingredients, purity and quality, and provides equivalent delivery over time as the brand-name version. However the makers of generic drugs agree that the approval process for generic biologics, like insulin, would be more complex than the current shortened process for other generic drugs. Anybody have a guess as to what the hold up is for this much needed and overdue generic insulin explosion?
1. Hello Grasshopper:
Two of the largest insulin makers, Novo Nordisk and Eli Lily, say they are opposed to any F.D.A. action that would approve generic insulin without clinical studies. Why the concern?
The Quality Control/Bioequivalency/Bioavailability is a great deal different of what the FDA requires from Brand Name Pharmaceuticals such as the two mentioned above and Generics. The FDA allows more "leeway and flexibility" in meeting standards that are necessary for a product to reach the Market for Generics, while those for Brand Name Drugs have more stringent controls placed upon them. In the end, the public who is in need of a drug(insulin or other) benefits the most. Of course with anything beneficial, a cost is always involved and that is the "high price of the medication".
Posted at 3:11PM on Jan 15th 2007 by BetterCell