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Why Isn't There A Generic Insulin?

Updated on October 7, 2014
Is a generic insulin on the horizon?
Is a generic insulin on the horizon? | Source
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Diabetes – A Rising Problem

According to the World Heath Organizaton, there are 346 million diabetics throughout the world. Diabetes is on the rise in the United States, with 25.8 million children and adults reported in 2011 by the American Diabetes Association, and 1.9 million new cases diagnosed yearly in people aged 20 years and older. This devastating disease causes heart disease, strokes, high blood pressure, blindness, kidney disease, neuropathy and amputation. Listed as the contributing cause of 231,404 deaths, it was the seventh leading cause of deaths in 2007. It is deadly, debilitating and expensive, with the total cost in the United States coming in at $174 billion dollars in 2007. Medical expenses for diabetics are more than two times higher than for people without diabetes. Much of that expense can be attributed to the enormously high cost of insulin.

Controlling Diabetes With Insulin

Diabetes is a chronic condition that occurs when the pancreas produces no insulin (type 1 diabetes) or doesn't produce enough insulin (type 2 diabetes) to control blood sugar. Type 1 diabetics are always dependent on insulin. Type 2 diabetics are treated first through exercise, weight reduction and a diabetic diet. If this doesn't work, oral medications are introduced. When all else fails, insulin is called for. Even though insulin Is absolutely necessary for many diabetics, this life saving drug has a hugh price tag.

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Why Is The Cost So High?

Insulin was discovered in 1921 by Canadians Fred Banting and Charles Best at the University of Toronto. Hoping that cheap insulin would be produced quickly, they sold the patent for a dollar. Eli Lilly managed to produce and sell 60 million units of purified pig and cow pancreas by 1923 at a fairly cheap price. Improvements were made over the years, each coming with new patents and price increases. Still, the price remained relatively cheap. In 1960 the price was only about a $1.00 a vial, and in the 1970s about $1.50. In 1978 Genetech made a huge breakthrough by managing to get bacteria to produce human insulin. This made insulin the first pharmaceutical biologic - a protein made biologically by living organisms. The next step was to combine yeast DNA with the gene for human insulin, producing miniature insulin making factories. Huge profits were attached with this breakthrough as the cost of insulin soared. In 1996 Analogs were introduced, where the human material is slightly altered to make a slower or faster acting insulin. These anaglogs are similar (analogous) but not exacly like human insulin. More patents – more profits – and today that same vial of insulin is about $100.00 or more. Since Insulin has been produced for so long, many of the patents have expired or will expire soon. Eli Lilly's patent for fast acting Humulog will expire in 2013, and its patent for Humulin expired in 2001. Novo Nordiks's Novolin insulin products expired in 2000. The patent for slow acting Lantus, produced by Sanofi-Aventis expired in 2010. Usually when patents expire generics appear on the market. So why isn't there a generic available for these insulins?

Biosilimilar, Not Generic

There will never be a generic insulin. The term generic refers to chemically produced drugs that contain the same active ingredients as the original drug. Since Insulin is a biological drug produced from living organisms (a biotech agent) , the biotech industry has argued that it can never be exactly reproduced like a generic. However, a highly similar or “biosimilar” agent could be produced. Up until recently there have been no guidelines offered by the FDA, so no biosimilar drugs have been produced. However, the 2010 Patient Protection and Affordable Care Act required the FDA to develop a system to approve “biosimilar agents”. In February 2012 the FDA released the first set of draft guidelines on biosimilar product development and by April of 2013 a total of four draft guidelines had been released, so it looks as if a pathway for the development of biosimilar insulin is finally open. It is projected that these products would be about 30%-70% cheaper than the original.

There are concerns about insulin biosimilars, however. Questions need to be answered concerning the potency, purity and effectiveness of the biosimilars. Also, there may be adverse reactions in some patients, so liability issues may need to be addressed. Because of these concerns, California has passed legislation, SB 598, that will require a biosimilar to be deemed “interchangeable” by the FDA as long as the patient is informed, and that a record of the substitution is kept for three years. Also, the prescribing physician must be notified within five days of the switch.

Although insulin biosimilars are certainly in our future, development of these products will take time. Lilly and Boehringer Ingelheim have formed an alliance, and it's application for LY2963016, which simulates Lantus, has finally been accepted for review by the European Medicines Agency. Mylan and Biocon are working on biosimilars for Lantus, Humalog and NovoLog, Sanofi has announced a biosimilar for Lantus that is moving into phase 1 development. Although biosimilars are projected to be a 10-20 billion dollar market by 2020 that's a long way off for those waiting for cheaper prices.

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While You're Waiting, There's Another Alternative

Walmart made a deal with Novo Nordisk to sell its Novolin R, N and Novolin 70/30 for $24.88 under Walmart's ReliOn brand. This is a great deal if you have no insurance or if you are on Medicare and have fallen into the donut hole. I've read many posts on this brand, and it has been mistakenly called “generic insulin”, but it is simply the same Novo Nordisk insulin at a steeply discounted price. If Walmart can negotiate this deal, it makes you wonder why our private health care insurance providers can't get a better price – but that's a Hub for another day!

© 2012 Margaret Perrottet

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    • Johnkadu123 profile image

      Johnkadu123 4 years ago from Toronto, Canada

      Great hub, I am interested in knowing whether diabetes is a pre-existing condition on American insurance policies. If so...what happens to sufferers? Sometimes I also think that attitudes towards diabetes patients directly influence public policy. For example some people consider it to be a preventable disease and are therefore much less inclined to treat sufferers with empathy.

    • mperrottet profile image
      Author

      Margaret Perrottet 4 years ago from Pennsauken, NJ

      Now that Obamacare (ACA) is in place, health care plans have to insure you whether you have a pre-existing condition or not. I never really thought about public opinion negatively affecting policy, but you may be right. Thanks for reading.

    • shiningirisheyes profile image

      Shining Irish Eyes 4 years ago from Upstate, New York

      You bring up a valid point here sir. I am ashamed to say I hadn't thought much about it until reading your well-researched article.

    • mperrottet profile image
      Author

      Margaret Perrottet 4 years ago from Pennsauken, NJ

      Thanks for stopping by and commenting, shiningirisheyes.

    • Sharkye11 profile image

      Jayme Kinsey 4 years ago from Oklahoma

      Very interesting hub! My husband currently takes 3 different types of insulin, and they cost us a fortune even with insurance. I know for a fact we are getting cheated by drug companies. We switched to a generic brand of another medication he takes, and saved almost $200! It is ridiculous. I hope they get something done about the insulin immediately. A lot of the people I cared for in the nursing home had diabetes related illnesses. Why? Because they couldn't afford insulin, so they did without. If insulin was more affordable, maybe there diabetes wouldn't be one of the leading causes of death.

      rant over. Thanks for this article! Voting it up!

    • mperrottet profile image
      Author

      Margaret Perrottet 4 years ago from Pennsauken, NJ

      Sharkye11 - I completely agree with you that it's a big rip off, and that it's costing lives. Thanks so much for taking the time to comment and vote - I really appreciate it.

    • Don Bobbitt profile image

      Don Bobbitt 3 years ago from Ruskin Florida

      Voted UP, Interesting and Shared!

      More should know about this situation. So, Thanks for the Hub.

      DON

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Don - Thanks so much for for voting and sharing this hub and getting the word out about this situation. It's important to all diabetics.

    • Peggy W profile image

      Peggy Woods 3 years ago from Houston, Texas

      I had no idea that insulin was so expensive! That is criminal. You are correct that if WalMart can negotiate better prices, it would seem that the insurance companies should have the same clout. Up votes and sharing.

    • harmony155 profile image

      harmony155 3 years ago from Atlanta, Georgia

      Yeah for Walmart prices!

    • Indian Chef profile image

      Indian Chef 3 years ago from New Delhi India

      Hi Mperrottet , Just to let you know Insulin is still pretty cheap than USA in India and we are getting generic versions of Insulin. Even new insulins like Glargine ( lantus) is available less than half price and I really liked your Hub. Voting it up and sharing.

    • Naomi's Banner profile image

      Naomi's Banner 3 years ago from United States

      Quite interesting indeed! It seems there are always resistants to coming up with a cheeper way as the big name companies want all the money for themselves. We will hope that technology will soon find a cure for diabetes altogether and the need for insulin, generic insilin will no longer be a need. Great Hub. Very informative. Thanks for your research and taking the time to inform us.

    • Bishop55 profile image

      Rebecca 3 years ago from USA

      My nephew (11 yrs old) is type 1 diabetic. This article hits home. Insulin is a major $$$ for drug companies, the cost will never go down. I can't even think about it very long or I get really angry. This was a good hub and I'm glad you've shared all this information. A lot of other people could prevent or reduce the diabetic population by losing a lot of weight and eating smarter. I hate seeing what my nephew goes through every day, and how much my sister struggles with the cost of medication he needs to simply live.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Peggy W - Yes, there's just no reason for the cost to be so prohibitively high on this drug. Thanks for stopping by and commenting.

    • mperrottet profile image
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      Margaret Perrottet 3 years ago from Pennsauken, NJ

      harmony155 - I'm normally not a huge fan of Walmart, but in this case they're doing the public a great service, so I agree. There's no reason why the insurance companies can't negotiate a better deal. Thanks so much for reading and commenting - greatly appreciated.

    • mperrottet profile image
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      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Indian Chief - Let's hope that this country brings down their costs as well. Glad you liked this hub, and thanks so much for voting and sharing. I really appreciate it.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Naomi's Banner - My husband is always hoping that they will finally find a cure for this debilitating disease. Wouldn't that be wonderful? Thanks so much for reading this and taking the time to comment.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Bishop55 - I'm sorry to hear that your nephew is diabetic. It's such a difficult disease to manage, and my heart goes out to your nephew and your sister. Let's hope that they find a cure, or a least in the meantime make the cost of insulin more affordable. Thanks for stopping by.

    • profile image

      psdaengr 3 years ago

      " If Walmart can negotiate this deal, it makes you wonder why our private health care insurance providers can't get a better price – but that's a Hub for another day!"

      Best guess- insurance companies merely compensate after individual purchases. Their tier pricing and co-pays reflect a much smaller population of potential buyers. Walmart actually bulk purchases from Nordisk, then uses their Relion brand as a loss leader, selling it below cost to pull more customers to their pharmacy. Some drugs at Walmart cost much more than at Costco, as I found when I needed antibiotics.

    • profile image

      psdaengr 3 years ago

      johnkandu1123: "some people consider it to be a preventable disease and are therefore much less inclined to treat sufferers with empathy."

      There's no accounting for what some people believe, but the medical profession has to bear some of the blame about multiple diseases being lumped together under the name "diabetes". Perhaps if there were a public TV spot showing a near anorexic just-diagnosed person with T1DM, and a morbidly obese person with T2DM . . . , or better yet, new names for each of the distinctly-different diseases that share only 1 symptom.

    • profile image

      psdaengr 3 years ago

      It is ironic, that with beef and pork production at world-wide record highs, beef and pork insulins aren't being produced in qualtity.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      psdaengr - thanks so much for reading and taking the time to leave such thoughtful comments on this article. It's greatly appreciated!

    • profile image

      Brubraja 3 years ago

      The article is great and all but the biggest problem is not discussed. The problem is that there are too many lazy overweight people out there with Type 2 diabetes who are unwilling to put down the twinkie and step on the elliptical causing people like me, a type 1 diabetic to pay the soaring costs for my life-sustaining medication. With Obamacare now open, my insulin costs went from $500/month to $750/month! I am now paying more for my insulin than I am for my mortgage. With a very severely asthmatic husband and an autistic son, I just cannot afford to pay these costs and because I have health insurance through my employer, Eli Lilly and PPARX refuse to assist me. I have a $6,500 annual deductible so I pay full price for my medicaions until I pay out the $6,500 so all of the type 2 diabetics out there causing my costs to skyrocket, thank you very much (add sarcasm here). It angers me because 90% of type 2 diabetics can eat healthy, exercise and take oral medications but they choose to be lazy and end up on insulin. Now with so many people taking insulin, the costs are absurd. So, thank you lazy people for making it even harder for me to pay for my medication. I do not have the option of taking oral medicine nor do I have the ability to rid my body of diabetes by exercise and healthy eating. I am stuck with this because my pancreas does not work yet you choose to be lazy having no consideration for those of us out there who have no other choice.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      That's really outlandish that you're paying such high costs. I'm surprised that your costs went up. I haven't noticed my husband's insulin prices go up at all, but I know it's different for each insurance plan. I can certainly understand your frustration, and I think it's a horrible situation. Thanks for reading and commenting.

    • profile image

      Pablo 1964 3 years ago from West Pittston, Pennsylvania

      My daughter is a type 1 diabetic. I have and employee-sponsored HDHP. The deductible, unfortunately, includes RX benefits. So, until we meet the deductible, insulin is quite expensive. Apidra offers a discount program where it will cover the co-insurance/co-pay up to a certain amount. One caution about the Walmart insulin: their low-cost insulin is the older, original type of insulin. It is not the type used by insulin pumps. As the article states, insulin formulas have improved over the years, causing the price to increase. So if you have a pump, chances are you will need to use one of the "newly" developed insulin. This is just based on my own research and consultation with our endocrinologist and is not meant to be used as medical advice.

    • mperrottet profile image
      Author

      Margaret Perrottet 3 years ago from Pennsauken, NJ

      Pablo1964 - thanks for the information about Walmart and Apidra. My husband still uses the older insulin, mainly because he doesn't use a pump and it is cheaper than some of the newer formulas.

    • profile image

      beeperbeak 2 years ago

      thanks for all of the insight on insulin pricing. i'm on medicare and using one of the advantage plans that has drup coverage included....i hit the donut hole at the end of the first quarter and when i went to get refills(3 mth supply) of lantus and novolog....it was over nine hundred dollars! up from twohundred and fifty before the donut hole....i'm struggling to survive on social security having lost a kidney to cancer and then cardiac arrest (now i have five stents) . i had to save up to order them and used the walmart relion in the mean time....but i do so much better on lantus... i doubt i will live to see the prices do anything but go up more...lets face it , it is a cash cow for the manufacturers, meanwhile many of us are making daily decisions of food or insulin, car repairs or insulins, where do i set the thermostat on my furance this winter or insulin....so for nine months out of the year i will pay three hundred a month for insulin. thanks for listening

    • mperrottet profile image
      Author

      Margaret Perrottet 2 years ago from Pennsauken, NJ

      beeperbeak - myheart goes out to you, and I wish that this drug were more reasonably priced. My husband lands in the donut hole after about six months and we are stuck with exorbitant costs as well. The donut hole is supposed to close up, but I don't think completely until 2018. It's a bad situation that I wish could be remedied.

    • profile image

      madashell 2 years ago

      "brubraja" is an absolute idiot to blame the Type 2s for costs of caring for a diabetes problem.....just as Type 2s can blame the type 1s. Not every type two is an overweight slob suffering only because they can't control their weight. I know because I am a lean Type 2 having battled diabetes for 20 years......Type 2s suffer the same amputations and diseases as Type 1s.....SO QUIT BLAMING ALL TYPE 2s for your problems.

    • profile image

      Lance 2 years ago

      Sounds like the FDA is blocking the production of some life-savings generic alternatives for nothing more than beuracratic reasons. Thanks government!

    • mperrottet profile image
      Author

      Margaret Perrottet 2 years ago from Pennsauken, NJ

      Lance - this whole process does seem to be blocked, and is taking way too long. Let's hope that by 2016 something is finally available. However, I'll bet that it will take a very long time for prices to come down even once the biosimilars are on the market.

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