How is a drug that has been around for nearly 100 years still not available as a low-cost generic?
That is the question that researchers recently asked about insulin, the diabetes treatment that was created in the 1920s but still can’t be purchased as a cheap generic.
Simply put, insulin is too complex for generic drug makers to manufacture cheaply and isn’t as lucrative as other products.
“Generic drugs have been a remarkable boon for affordability and access to potential medicine. That progress doesn’t spread evenly across all kinds of medicine,” said Dr. Jeremy Greene, an associate professor at Johns Hopkins and co-author of an article on the subject in the New England Journal of Medicine.
Insulin can cost an uninsured patient between $120 to $400 per month, the journal article said. By comparison, some generics would only cost about $4.
The 1984 Hatch-Waxman Act made it easier for generic drugs to enter the market.
Under the law, a brand-name drug can become a generic after its patent expires. A generic drug maker can apply for regulatory approval to make an exact copy of the product.
Because a generic manufacturer doesn’t have to put in the billions of dollars in research as the brand name company did, it can sell the product for far less, sometimes even 80 percent off.
From 2003 to 2012, generic drug use is estimated to have generated more than $1.2 trillion in savings to healthcare systems. About 85 percent of all prescriptions are filled with generics, according to the Food and Drug Administration.
While generics offer all sorts of low-cost alternatives, manufacturers often choose to copy more profitable blockbusters such as anxiety drugs, Greene said.
Another hurdle is insulin is hard to make compared with more traditional drugs.
Insulin is also considered a biologic drug, meaning it is made from living organisms such as protein or tissue instead of a regular drug made from chemicals. A biologic is considered more complex than a regular drug and therefore more difficult to manufacture.
And insulin is an injectable, which is more difficult to put together safely than just a tablet, Greene said.
But market forces weren’t the only reason insulin remains unavailable as a generic. Throughout the years brand-name manufacturers have made tweaks to the formulation, making improved versions, for example, that are long-acting.
This practice, called “ever-greening,” essentially preserves patent protection because of tweaks and improvements to the existing formula.
Drug companies are starting to receive more scrutiny from regulators over tweaking their product to forestall generic competition.
New York State sued Actavis last year for making a change to the dementia drug Namenda to extended release. The lawsuit claims Actavis attempted to force patients from the regular version, which loses patent protection this year, to the extended version that is still protected.
“A drug company manipulating vulnerable patients and forcing physicians to alter treatment plans unnecessarily simply to protect corporate profits is unethical and illegal,” New York State Attorney General Eric Schneiderman said when the lawsuit was announced in September.
Greene cautioned that the insulin process isn’t consistent with other types of “ever-greening.” He said researchers were more interested in finding new applications and innovations with the drug, rather than slight tweaks to stave off generic competition.
For instance, manufacturers started making insulin that didn’t rely on animal tissue extracts that could have impurities. Now manufacturers use human DNA.
One pathway for getting cheaper insulin is through biosimilars, which are biologic drugs that are similar to their brand-name counterpart. The FDA approved the first biosimilar from Sandoz that closely resembles a cancer treatment called Neupogen manufactured by Amgen.
Greene said that biosimilars would be cheaper than the brand-name product, but not as cheap as generics. For example, some biosimilars available in Europe are only about 30 to 40 percent cheaper than their branded counterpart.
