Why is there no generic insulin?

Researchers from Johns Hopkins University have delved into the history of the diabetes drug insulin in the hope of understanding why a generic version has never been made available in the US. Writing in the New England Journal of Medicine, Drs Jeremy Greene and Kevin Riggs explained that pharmaceutical companies have been “evergreening” - ie, make a series of incremental improvements to - insulin since its initial discovery by a University of Toronto medical team in 1921.

In 1923, the university gave drug companies the right to manufacture insulin and patent any improvements. In the 1930s and 1940s, pharmaceutical companies developed long-acting forms that allowed most patients to take a single daily injection. In the 1970s and 1980s, manufacturers improved the purity of cow- and pig-extracted insulin. Since then, several companies have developed synthetic analogues.

Not only has each improvement to insulin kept it under patent, but it also means manufacturers have less incentive to make a generic version that doctors perceived as obsolete. Patents on the first synthetic insulin expired in 2014, but newer forms are harder to copy, so the unpatented versions will go through a lengthy FDA approval process and cost more to make.

The authors claim that if unpatented insulin does come on the market, it may cost just 20-40% less than a patented version - which can cost $120 to $400 per month without prescription drug insurance and is, according to Riggs, “an inconvenient medicine even for people who can afford it”. The authors thus suggest that their research has “implications for policy and practice”, in order to protect those diabetes patients who can’t afford to protect themselves.

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