– How does Insulin not have generic versions compared to something like Tylenol?
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Tylenol, and most drugs, are chemical compositions. You make them with the same ingredients in the same amounts and they turn out exactly the same each time. Insulin is a biological creation, it’s made by genetically modified bacteria. Since each bacteria is unique, each batch of insulin is unique. They’re all very similar and all work the same, but they’re not exactly the same.
Essentially each time you make insulin it’s all new and it requires more oversight and testing. It’s simply too expensive for most companies to go through the approval process for insulin each time they make it so only a few companies are willing to invest the resources to manufacture it.
Well Tylenol is a brand name and insulin isn’t so any “generic versions” of insulin would also just be called insulin. What I think you’re asking though is why there isn’t a cheaper version of insulin. There are a couple of reasons for that, let me break it down for you.
The first issue is that here in the United States there’s a strong corporate monopoly on insulin.The corporations don’t have patents on insulin itself, but they have patents on processes to create it, patents on many objects for patients to administer it and patents to deliver and store it. They also have a stranglehold on the market and excessive money to buy/sue any “generic brand” competitors.
The other issue is that insulin is pretty hard to make and a little risky. It requires a ton of startup capital, scientists, infrastructure, lab equipment and other crazy futuristic things, all of which are insanely expensive. Also, if you mess up even a little bit, a person administered a bad dose of insulin could die.
That said, if you think you’d be able to produce a “generic brand” of insulin at a cheaper rate, please try. You’d be doing the whole country a service.
There is cheap insulin but insulins are not created equally.
More advanced (analog) versions tend to be protected by patent law and pharmaceutical companies can make incremental modifications to keep those rights.
Circumventing these takes a lot of effort, both from a research/certification perspective and finances.
Creating or rebuilding an insulin is also considerably harder than simply cooking ibuprofen.
You essentially have to manipulate bacteria or yeast to produce it for you.
I’m assuming your question revolves around “costs”. There is affordable insulin available at every Walmart for $25 a vial. Fact.
What nobody discusses is that there are different types of insulin. The Walmart version of insulin is older and requires the diabetic to strictly eat regularly and properly in addition to taking the insulin 4-5 times per day.
Some pharmaceutical companies created “new” long acting types of insulin. These new improved insulins provide “convenience” to diabetics by not having to be as strict with eating, and require only 1-2 injections per day. These are the insulin types everyone is outraged about concerning cost.
Unfortunately this comment will be downvoted heavily because it runs counter to the evil big Pharma crowd who use the word “insulin” broadly to mean ALL, but then only reference the new, improved insulins pricing to further their point and outrage.
I’m not debating drug pricing either way only that the insulin pricing issue and any issue should be presented with all the facts that we all be “informed” 🙂
TLDR; Inexpensive cheap “generic” insulin is available, but requires strict eating & multiple injections. Improved, convenient, longer lasting insulin is available and considerably more expensive for that convenience.
You have to understand patents.
The government decides who owns a patent and what kind of protection a patent has. Patents generally expire, but companies can fight to keep their product protected for a very long time.
People who need insulin have no choice but to buy it so companies want to keep rights and charge a fortune.
It does, and it’s also both cheap and generally easily available. Counter that with: it is also much more of a pain in the butt to manage your diabetes with.
The medical research field is pretty regularly inventing new variations of insulin. Those new variations are not generic yet, as their patents haven’t expired. Those new variations are so much easier/convenient to use than standard generic insulin that most people would rather pay the extra for them.
Two extra bits on this discussion to keep in mind: 1. A lot of misinformed people lump all insulin variants as “insulin”, which distorts the discussion on insulin prices. 2. These new variants tend to make life so much easier for diabetics that they feel the variants should become the new standard and replace generic insulin entirely.
Acetaminophen/paracetamol are not constantly being reinvented with new (better) variations, so that isn’t really a good comparison.
It can’t have a generic because it is a large molecular medication. However, it can have a biosimilar. Biosimilar laws are different from generic in that they don’t have to be equivalent to the original. There is a separate approval process for proving equivalence. We have several biosimilar insulins and one interchangeable biosimilar insulin. Manufacturers just have not been interested in getting approvals.
Humira will go off patent next year and there are something like 7 versions which have tentative approval.
At this point, all versions of insulin currently for sale are effectively generic in that the last of the patents covering them and their manufacturing processes expired in 2016. Anyone could manufacture and sell them, but the companies that make most of it are NovoNordisk, Sanofi, Pfizer, and Eli Lilly.
It costs about $25K per kg to manufacture regular human insulin, $69k per kg for genetically engineered long-lasting insulin, and about $100k per kg for insulin analogs (stuff that isn’t insulin, but controls blood sugar like insulin with some differences in how quick it works and how long it lasts). That sounds expensive, but people only need tiny amounts. A “unit” of insulin is 34.7 **micro**grams and people might use 200-300 units per day (7-10 milligrams).
What does that mean for cost? A vial of insulin costs $3 – $6 to produce and package, and will sell anywhere from $170 – $400 per vial for 100 iU/mL. There’s a 55x – 65x mark up, on average, in the USA. This is why Gov. Newsom of California proposed the state start making it’s own insulin; which is a fine idea and best of luck to him in pulling that off.
The men who developed insulin, Fredrick Grant Banting, Charles Herbert Best, J J R MacLeod and James Collip gave it free to the world. Banting Best and Collip sold the patent to the University of Toronto for $1 who then licensed it out for a 5% royalty with the procedes going to medical research so that no one company would hold a monopoly and commercially exploit the drug.
Even so MacLeod tried to get them to reduce the royalty.
Essentially insulin has always only been the generic version.
In case you weren’t aware, California is spending $100 million to manufacture insulin.
[https://www.healthcaredive.com/news/California-manufacture-insulin/626916/](https://www.healthcaredive.com/news/California-manufacture-insulin/626916/)
Hopefully this will start to make a huge difference – with either California expanding production and selling to other states, or with other states copying the same model.
I think it’s kind of like community fiber Internet – it’d be nice if it wasn’t necessary, but since it is, I’m glad people are doing what is within their power.
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