Why has Insulin not gone to the Generic Category. Is it number of years. Is it possible to have a Generic Insulin. If there is some reason that it is not generic then there should be a push to make it Generic. This is truly a commodity now. It is definitely something being discussed. Here is a link to a study.
hi @cookmh Mark and welcome to Type One Nation. I hope the forum isn’t getting tired of me.
the webmd article ain’t telling the whole truth, but to do so you have to have a lot of experience,
“generic” after patent expiration for a biologic drug, is NOT the same as for when a chemical drug patent expires. a chemical drug (let’s use a real simplistic chemical) such as NaCl (salt). once it is formed, chemically is very easy to synthesize (or copy if you will) . So easy, in fact that the patent really protects multiple billions of research and development and clinical trials and launch and yes, even the liability. once it expires, boom you have 7 different companies that can make it for $1 a ton.
the simple crystal can be studied and, essentially, copied,. that’s the big take-away.
a biological drug, is often the result of DNA engineering. The research goes into making the nucleus of lets say a yeast cell (omg, insulin is a GMO!) . Inside this yeast cell a specific protein chain is introduced to the DNA of the nucleus and the yeast multiply happily in sugar and water. Then the nuclei are smashed and all but the specific protein chain is removed through purification. Then sometimes these chains have to be modified and they join at specific and exact molecular spots… until a very complex, potentially thousands of bonds and thousands of potential glycolizations take place to form a therapeutic protein such as insulin. Now I am a engineer, not a genetic scientist, so I made this simpler than it really is, so forgive me if I offended any PhD’s out there.
trying to copy a biologic protein is far more difficult than a simple chemical copy. These are so difficult, that they are not typically called generic but they are called “biosimilars”. because there just isn’t any possible way to actually copy them without owning the little yeast starter cells (factories) which are considered property of the original company’s work. YOu start with the end product and then you have to cultivate your own starter cells. Massively different and difficult. I know I am belaboring a point but even a copy isn’t an exact copy… the best and closest you can get is “similar”.
so - long after the patents expire (and most are completely expired) there still are huge and expensive efforts to reverse engineer a cell and process to make a biosimilar, and most if not all of the clinical trials and testing and real expense in proving that what you got is “similar” to the original insulin is still on the copying company…
typical backroom generics type companies are not able to make cheap copies of them… so they are limited.
There actually is biosimilar insulins… one of them is Amdelog. Ta-da! biosimilar fast insulin and Basaglar.biosimilar lantus why isn’t is $5 a gallon? well because it was almost as hard and expensive to make as the original. so they are not and will not be cheap.
well, that’s the reader’s digest version anyway. take what you like and leave the rest.
Thank you. I have a Psoriasis drug that I take and it cost $5K per month, but I can just get a card and get it for $5. I am amazed that my boy would die without insulin and that they can’t some how make it cheaper.
Hi @cookmh Mark. The morality of charging a lot for a necessary protein, that you die without, is a different thing. I agree that it should be different. It (insulin) is hard to make though, the sterility requirements alone are staggering. Our choices seem to be limited at the moment.
maybe the giant walmart will make a humalog like insulin soon, the r isnt far off and would work in a pinch for pumps, and has always worked in mdi, i lived off n and r from walmart for close to 22 years