Today, three companies control virtually the entire global market for insulin.

The creation of insulin for human use to treat diabetes is a relatively well-known story: in the 1920s Toronto surgeon Frederick Banting developed an insulin injection from animal pancreases after a series of experiments on dogs. He sold his patent to the University of Toronto with the intention of making it an accessible medicine for those suffering from diabetes, for whom lack of insulin treatment would mean death.

So how is it that the insulin available today has come to be produced by only three major companies and sold at exorbitant prices when the sale of the patent was intended to make insulin accessible to all who required it? 

Why isn’t a generic version of insulin available at a more affordable price?

The insulin patented by Banting was derived from the pancreatic tissue of animals. Rights to the patent were granted to Eli Lilly in the United States and Novo Nordisk in Europe, under the assumption that large scale pharmaceutical production would contribute to greater public-access of insulin. Insulin was generated by using animal tissue until the 1970s, when scientists developed and began to manufacture a human insulin by using recombinant bacteria and DNA. In the 1990s, analogue insulins were developed. Each improvement that a company made on the original insulin patent was then patented. 

In a process known as “evergreening”, companies created a myriad of patents on each development or improvement made to insulin, effectively rendering some element of the design perpetually in patent. Insulin delivery systems, like pumps and pens, are also subject to patents. All of this makes it difficult to replicate insulin in a generic version. 

Today, pharmaceutical manufacturers - Sanofi, Eli Lilly, and Novo Nordisk - control most of the world’s $27 billion insulin market, using a complicated web of regulations and patents to keep a hold on it. And manufacturers have a large vested interest in insulin prices. A fair portion of each of the three drug-makers’ revenues are based on insulin products. Especially for Novo Nordisk - a little more than half of its self-reported revenue in 2018 came from insulin products. 

A further hindrance to the development of a generic insulin is that insulin, although it is classified as a drug, is actually a biological material, or “biologic”. Drugs are chemically synthesized, but insulin is produced through the synthesis of complex proteins in a living environment unique to each formulation. Generic drugs can be replicated by ingredient and evaluated by straightforward blood tests, and are approved by the FDA when it determines a generic version of a chemical is interchangeable with the original drug. Because of their complexity, generic versions of biologics must be tested through clinical trials, which adds considerable time to the approval process.
Recently, the FDA announced that it would reclassify insulin as a biologic in 2020. But does this reclassification mean that a generic version of insulin will soon become available? Not likely, argue authors in a recent opinion piece in BioDrugs. When reclassification takes place in March, none of the insulins currently in use, including Insulin Lispro, the follow-on insulin produced by Sanofi, will be eligible for consideration as biosimilars. A product must be designated as biosimilar before it can be approved as an interchangeable design — a lengthy and expensive process for producers. The authors speculate that the March rollover of insulin could mean upwards of a year delay in producing any kind of interchangeable or generic insulin product. 

“There hasn’t been any real major change in insulin in the last 10 years or more besides playing around with some elements of it” 

So, what’s at stake? People can’t survive without insulin. In the United States, there are currently 7.4 million insulin-dependent diabetics. And prices have soared. Insulin-makers are facing a serious financial stake as critics debate over whether insulin’s improvements are worth its new sticker prices. “There hasn’t been any real major change in insulin in the last 10 years or more besides playing around with some elements of it.” 

Newer is not inherently better - “it obscures the fact that the insulin made in the 80s would be just as good for the average diabetic today.”  

(chart via @BloombergLaw)