Why Does Insulin Cost More Than Ever? It's All In The Way It's Made

Complex competition and lack of clear FDA guidance make insulin manufacturing an often expensive proposition.

| Jul 27, 2009

Banting Gives It Away - Insulin was discovered in 1921 by Fred Banting and Charles Best. In a generous gesture that unfortunately didn't start a trend, they sold the patent for a dollar so that cheap insulin would quickly become available. It worked like a charm: within two years, Eli Lilly had sold 60 million units of its purified extract of pig and cow pancreas.

Patents Premiere - The first insulin did not last long in the body, forcing people with diabetes to inject themselves several times a day with the sword-like needles that were available at the time. In the 1950s, longer-acting insulin was developed to reduce the number of painful injections. Each improvement came with a patent, and each patent came with a price increase. Still, even with the new patents, insulin was fairly cheap. Many people recall paying less than a dollar a vial for insulin in the 1960s. Even in 1975, our former editor-in-chief paid only $2.99 a bottle.

The Era of Biologics - In 1978, researchers at the biotech company Genentech did something that had never been done before: they manipulated bacteria into making human insulin. Insulin became the first pharmaceutical biologic; that is, a protein made biologically, by living organisms, instead of chemically. The making of insulin as the first biologic was the dawn of the biotech era.

Eventually, yeasts were also used as tiny insulin-making factories. Once the gene for human insulin was inserted into one yeast DNA, the yeast did what yeasts do: it multiplied ad infinitum, and each new yeast came with a little copy of human insulin. This breakthrough, naturally, carried with it a big, profit-making patent.

Advance of the Analogs - In 1996, the Food and Drug Administration approved the first insulin analog. Newer insulins are called analogs because they're analogous to human insulin: like it, but not quite exactly. Before being put into the yeast, the human genetic material is slightly changed, to produce slower or quicker acting insulin, for instance. Each one of these improvements comes, of course, with a patent. And all these patented insulins cost - big time.

Where's the Generic? - Eventually, patents do expire. And when patents expire, generics generally leap into the market. Why not generic insulin? Because even though biologics have been on the market since the 1980s, the FDA has never told the generic companies how they can get generic biologics approved. There are no official guidelines for approval of generic insulin.

Generic Shortcuts - Insulin guidelines would need to answer one basic question: whether generic insulin manufacturers can use the usual generic shortcuts to approval. When generic manufacturers copy standard drugs, they aren't forced to repeat the exhaustive clinical testing that the drugs went through to get approved in the first place. All they need to prove is that the generic version contains the same active ingredient as the name brand, in the same purity, quality, and strength. The generic maker isn't forced to start from scratch and re-prove the drug's safety and effectiveness. This shortcut is called "piggybacking" on the clinical studies originally done by the drug company that invented the drug.

FDA Guidelines Are a No-Show - Because the FDA has not supplied guidelines to the generic companies on how to achieve approval of generic insulin, they don't know what to do. Can they piggyback or not? The FDA said in 2001 that it was developing guidelines for approving generic insulin, but it never did. Now the FDA says that it no longer plans to issue guidelines for each biologic medicine, one by one. Instead, it's announced that it will develop global guidelines applicable to all biologic generics, from simple insulin to the latest super proteins. This announcement has caused a lot of protest because such complex guidelines would take much longer to produce than a single set of guidelines targeted to insulin alone.

No Piggybacking for Biologics, Says the BIO - Some say the FDA's foot-dragging has been influenced by lobbyists from the Biotechnology Industry Organization (BIO), which represents the biotech pharmaceutical companies. The BIO says that the shortcuts awarded to conventional generic drugs don't apply to biologics, even simple ones like insulin. According to the BIO, the critical element in regular drugs is simply the active ingredient, but for biologics, it's different: it's all about the little creatures in the manufacturing process, and that's much more complex.

Just Give Us A Guideline - For safety reasons, Novo Nordisk and Lilly both oppose the FDA allowing generic insulin to piggyback without repeating clinical studies. But generic drug makers note that biologic insulin has been around since the eighties. It's relatively simple, they say, and costly clinical trials would only raise the price prohibitively high. They concede that the approval process for generic biologics should be more stringent than for conventional generic drugs. They just want some guidance from the FDA so that they can get started.

Patents Pending - In any case, some biotech companies are beating the generics to the punch by manufacturing cheap editions of their own expired patents. For instance, Novo Nordisk makes ReliOn/Novolin, which is simply its patent-expired biologic human insulin. It's sold at Wal-Mart for $19.96 a vial.
The problem is, most people favor the newer insulin analogs over the older varieties of insulin. That's one reason the big pharmaceutical companies aren't too worried. Even if FDA guidelines are created and generics do make it to market by 2008 or 2009, the major companies don't expect to lose many patients to generics. Insulin analogs themselves could become targets for generics in 2014, when their patents begin to expire. But by then, the major drug companies are confident that they will have newly patented next generation insulins on the market.

Power to the Diabetic People - In spite of everything, consumers do have influence when it comes to generic insulin, if they choose to wield it. As well-known diabetes blogger Scott Strumello states, "Regardless of which insulin we use personally, we should not tolerate regulatory inaction regarding generic insulin. All people with diabetes should urge their legislators to support legislation that removes barriers to price competition in the insulin market."

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Categories: Community, Diabetes, Diabetes, Food, Insulin, Novo Nordisk, Research, Type 1 Issues


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Comments

Posted by Anonymous on 4 August 2009

Nicolae Paulescu, a professor of physiology at the University of Medicine and Pharmacy in Bucharest, was the first one to isolate insulin, which he called at that time pancrein, and published in 1921 the work that he had carried out in Bucharest. Use of his techniques was patented in Romania, though no clinical use resulted...

Posted by Anonymous on 4 August 2009

Generics? You mean the legalized theft of someone else's invention?
All I know, is that I'm glad I'm not using some free pig based insulin. The golden liquid that keeps me alive? Yes I'm willing to pay premium for that. I rather save money on something else that's not as important.

Posted by Anonymous on 4 August 2009

I think it is ridiculous what us diabetics have to pay for insulin. Not everyone can afford $100 vials...that is without insurance and even the price with insurance is unnecessary. I guess it is because Novo Nordisk and Lilly realize that we need the drug to survive so we don't have a choice..it's sad what drug companies will do to make money.

Posted by Anonymous on 4 August 2009

The fact that insulin does not come in generic form is ridiculous. I have been on insulin for 47 years, and am now having a hard time paying for it. Someone needs to do something about this. It's not as if we are taking insulin for the hell of it.

Posted by Anonymous on 5 August 2009

Please every diabetic in the country should forward this information to their congressmen.We must demand action. It is a crime that no generic insulin is available.My insulin costs over $7,000 a year. Billions is spent on insulin every year. Please take the time to help all diabetics.

Posted by Anonymous on 5 August 2009

"For safety reasons, Novo Nordisk and Lilly both oppose the FDA allowing generic insulin to piggyback without repeating clinical studies."
The article should say "Citing safety reasons, ..." Their real motive may not be what they claim. They are sitting on a goldmine and they know it.

Posted by Anonymous on 5 August 2009

Walmart sells Novolin insulin for $23.67, buy the exact same insulin somewhere else with a different label: $46.99. Buy the exact same insulin in a pen fill at $145.00, that works out to $96.00 a vial. $145/1.5

Posted by Anonymous on 5 August 2009

This an excellent example of why our healthcare cost are out of control and why they won't try to really find a cure for diabetes because the drug manufactures are making a ton of $$$ and don't want to give that up. Every other drug that has allowed generics to come to market has saved money why not insulin??

Posted by Anonymous on 5 August 2009

My son who has had diabetes for 35 years, since he was 3 years old can't control his BG on the DNA insulin, so he gets the natural pork insulin from Canada and he's doing so much better on pork insulin.

Posted by Anonymous on 5 August 2009

So all this doesn't help the patient with no money or is in the Medi-gap. Folks are cutting their doses way down, enough to stay out of immediate danger but causing serious deterioration of previous stable continues. The companies are not overly generous.

Posted by Jerry1423 on 5 August 2009

As an insulin dependent diabetic for 34 years I am not only fed up with the high cost of insulin, but the fact that animal based insulins are not easy (impossible) to get around here.
I feel strongly that I was in better control, and felt better when I was taking the animal based insulin, and the most I remeber them being ws $23/vial. Animal based insulins have hormones that are not in the man made insulins, and were beneficial to a person's health.
There are many people who have been on insulin from 50 to more than 75 years, which means more than half their lifetime they were on animal based insulin - so how bad could they have been?

Posted by Anonymous on 5 August 2009

Great picture w/the article. Maybe next time you should have the model take the cap off the plunger?
Nothing wrong w/making a profit - but making exorbitant profit off people's lives is a whole 'nother matter.

Posted by Anonymous on 6 August 2009

You can buy the cheapest insulin for $20 a vial. If you want the highest tech, easiest to use, best; you pay more. Quit whinning and either use the cheap stuff or support new reseach and development. We have the best health care system in the world. The socialists want "change", as a Type 1 for 37 years I prefer to pay for the best and live a while longer.

Posted by Anonymous on 6 August 2009

It is not the lack of guideliness which prohibites generics from coming. The sheer quality demands of producing and transporting insuline does not make it profitable for generics firms to produce and market insulin at generic price levels. There is generic insuline in countries such as India and I have seen it. Believe me, you do not want that the quality levels of that insulin.
Be glad you are in a position to access good quality medication. in Africa someone dianosed with insulin dependant diabetes dies within 1 year becasue of the lack of distribution ans cooling facilities....

Posted by Anonymous on 6 August 2009

My annual co-pay for the two insulin pens I use is $640.00 & I'm using 90-day mail order pharmacy services. If I were getting it locally on a 30-day basis it would be much higher. This is outrageous & unfair as there should be a generic option. I also inject Symlin before meals & take Metformin. In total I pay $1040.00/year in co-pays for my four diabetes meds. I'm grateful for the coverage that I have, but the lack of generics is costing me a lot of money. WE NEED HELP to get generic insulin on the market!

Posted by Jerry1423 on 7 August 2009

I noticed the plunger cap still on the syringe too.
I really wonder what the people (who took the picture) were thinking when they did that.

Posted by Anonymous on 12 October 2009

Hmmmm. My son is diabetic. He is using the same insulin as always - humilin N & R by Lilly. I guess those yeast needed a wage increase because it has gone from 18.00 to 50.00 since he started. PC's on the other hand have gotten much cheaper and faster - something wrong here.

Posted by Anonymous on 22 December 2009

" Posted by Anonymous on 4 August 2009
Generics? You mean the legalized theft of someone else's invention?
All I know, is that I'm glad I'm not using some free pig based insulin. The golden liquid that keeps me alive? Yes I'm willing to pay premium for that. I rather save money on something else that's not as important."

Man, I loved the Beef and Pork Insulin of old a wish they still sold it. Better than the Humalog and Lantis I'm on now. You obviously never used it. No loss of quality there...they keep updating to keep you paying higher prices. Money must grow on trees around your house.

Posted by shirlinfla on 22 November 2010

I can't understand why the FDA won't approve of having a generic insullin.So many people are suffering with diabetes. So many companies are making big profits. Is it just greed? Don't these companies get goverenment funding for research and we still pay 300% over the costs on prescription drugs; and they tell us that they need it for research.

Posted by Anonymous on 28 July 2011

There are a few very right wing comments here that have no basis in fact or reality. The National Institutes of Health in a government funded body that does basic research that a lot of biotech and other pharmaceuticals use to create their drugs. Government is the people, it's not some horrible entity that's trying to steal patents from businesses and give them away. In a democracy, people are the government and we should be calling the shots but it's quite easy to see that lobbyists have more power than the people.

Posted by Anonymous on 27 January 2012

I think it's about time to see cheaper Humalog and Lantus, as well as novalog and levimier. The big Pharm co.s are killing and maiming diabetics everywhere because of high insulin prices and should be held accountable. Diabetes is a treatable disease "If", you can afford it. It's about time Lilly and other makers start being responsible and ethical instead of Murderous assess!

Posted by Anonymous on 19 April 2012

Just had to pay $80.00 for a vial Lilly N! Wtf?! 20.00 more than 3 months ago, 30.00 more than 8 months ago and 60.00 more that 10 years ago! I'm mad as hell and hope the families and loved ones of the Eli Lilly executives all get hideous chronic illnesses

Posted by Anonymous on 2 June 2012

I just paid another $9. for my Lantus Insulin this morning,that makes the total increase from the first of the year at $21. a vile is now $138. I live on a fixed income,we don't have money trees in Montana like the Politicians do in the District of Criminals. I am so mad about this I could spit bullets,where is the justice?? Like someone said earlier,this is my life your talking about.

Posted by beartoo on 22 June 2012

My meds this morning cost me over 850.00 plus for 90 days. I am on SSI which is a very fixed income and a very little increase. If my meds get any higher I may not have to worry about it because I will stop using it and die. What choice will we have?

Posted by Anonymous on 2 October 2012

I'm in a HMO. My doctor changed my insulin from Lantus to Novolin N a couple of weeks ago during my regular checkup. One of the reasons he gave was that their pharmacists say that Lantus is expensive and that doctors should try to avoid it, if possible. Now I know why - a recent price hike.
I was in Canada last month. Insulin there is only one-third the price that it is here. There is no reason why insulin manufacturers should enjoy greater profit margins in the US than in Canada.

Posted by Anonymous on 16 July 2014

Obamacare is trying to kill me! Now pharmacists (at the insurance companies suggestion) are advising patients (me) to change insulin because I can't get what I've been using.
I told them I would contact my insurance and quite frankly that they were crazy if they think they can over-ride my doctor's orders.
Next day, received text that my RX was ready...
Get lobbyists out of the way and let's get the cheaper generics going!!!


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