Generic Insulins Out of Reach for Now


By: Clay Wirestone

A Diabetes Health reader writes in to ask: Is there a generic alternative to Humalog insulin? If so, what is its cost compared to Humalog?

Generic drugs are amazing. They offer lifesaving promise for a cheap price tag, and given that the underlying drugs have been tested and proven, there’s no doubt about safety or effectiveness. But don’t expect to see generic “human” insulin any time soon. If you do spot it eventually, don’t expect it to be too cheap or widespread.

It seems that the complex manufacturing involved in insulin drugs isn’t easily duplicated. The processes are so complicated–and government guidance in the area so lacking–that there are still no generic alternatives to insulin brands with expired patents in the United States.

Humulin insulin, for example, saw its patent expire in 2000, but Eli Lilly still sold $1.3 billion worth of the brand last year. Lilly’s patent on Humalog will expire next year, but its most worrisome competitor, a company in India associated with Pfizer, called off its generic insulin work in March. That’s expected to keep Humalog sales strong into the near future.

Some semi-generic forms of human insulin are available in other countries, but they’re called “biosimilars” because they’re only similar, not identical, to the name brand stuff. Patients don’t necessarily react to them in the same way.

The US Department of Health and Human Services is working on rules for these generic insulins, and a plant to manufacture them is being built. But companies will still have to run tests on the new insulins–something they don’t have to do for most other generic drugs–which will slow their introduction even further.

Ultimately, insulin is a highly specialized drug that’s used by a relatively small number of people. The complicated processes needed to make it are in the hands of a small number of companies. And while people overseas have access to “biosimilars,” they are still a fraction of the market: $3 billion of $18 billion total.




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