Wanted:  Cheaper, Effective and Readily Available Generic Insulin

Generic drugs for birth control, chemotherapy HIV and anti-viral are readily available over the counter, but if you ask for a generic of insulin there is none.

Branded insulin costs a whooping $120 to $400 for one month’s supply. The website Insulin Nation in 2014 interviewed insulin users about some of their dilemmas. One patient totally surrendered her doctor’s visits and teeth amenities just so she could purchase her medicine. When insulin went on a discounted sale, another patient stocked up when he found it for a good price, and sent extra to a family member who couldn’t afford it.

If generic insulin would be mass produced and sold at a lower price compared to the branded ones, it would certainly be a gigantic advantage to five million diabetic Americans who are dependent on insulin to treat their Type 1 and Type 2 diabetes, lethal illnesses if left untreated.

Other pharmaceutical firms start producing generics when the patents of big-name drug-makers’ expire. The cost of generic drugs is a lot lesser, due to the fact that their producers did not bear the high cost of their research, discovery and development.

In the case of insulin, this did not transpire, even though it was first patented in 1923. The due to patent-refreshing and generic producing companies’ unwillingness to undertake production of the insulin protein, which is hard to duplicate, is keeping insulin patented and costly, according to a two physician-researchers report in the New England Journal of Medicine today.

“It’s hard to say that contemporary patients who cannot afford their insulin are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago.”

Some researchers and journalists have accused drug companies of “evergreening,” or making inconsequential improvements to drugs whose patents are near expiration, in recent years.  The trivial tweaks let drug manufacturers invigorate their patents and edge out the competition. 
Although, these petty improvement made to insulin could not be really described as a straightforward chronicle of evergreening. Companies have made insulin faster-acting, longer-lasting, and unadulterated in the recent years.

Researchers Jeremy Greene and Kevin Riggs wrote in the New England Journal of Medicine, that insulin today is demonstrably safer and more convenient to use.  But are the latest insulin therapies worth it for everyone? “It’s hard to say that contemporary patients who cannot afford their insulin (let alone the patent-protected glucometers and test strips required to adjust the dose) are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago,” Greene and Riggs write.

So why aren’t generic companies in the running in producing those older-version insulins? Insulin under a microscope is much larger and more complex than most remedies, making it difficult for companies to duplicate. Insulin is regulated differently by the U.S. Food and Drug Administration also regulate differently from less complex drugs.  The approval process is often more pricey. “Generic-drug companies have evidently not considered it worthwhile,” Greene and Riggs write.

Hopefully, this may alter soon. A U.S. generics company is working on FDA approval for its own insulin. A diabetes website, dLife, argued in 2013, it would be a blunder to hang back for the whole drug-approval system to work on its own. After all, over the last 90 years, it hasn’t.

 

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