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Why Isn't There A Generic Insulin?

Updated on November 4, 2017
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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