BMJ 2015;350:h1535 doi: 10.1136/bmj.h1535 (Published 20 March 2015)
Page 1 of 2
News
NEWS Insulin has never become a cheap generic drug in the US because of companies’ small changes to “evergreen” the patent Susan Mayor London
Drug companies have made incremental improvements to insulin that have kept it as a patented medicine in the United States for more than 90 years, shows a study tracing the drug’s history.
“The history of insulin highlights the limits of generic competition as a public health framework,” said the study authors, Jeremy Greene and Kevin Riggs, of Johns Hopkins University School of Medicine in Baltimore, USA, writing in the New England Journal of Medicine.[1] They warned, “Nearly a century after its discovery, there is still no inexpensive supply of insulin for people living with diabetes in North America.” To investigate why insulin is still not available as a low priced generic drug, Greene and Riggs traced its development over the past 100 years and found that drug companies have made incremental improvements that have extended their patents.
Insulin was discovered by a team at the University of Toronto, Canada, in 1921. In 1923 the university, which held the first patent for insulin, gave drug companies the right to manufacture it and to patent any improvements. During the 1930s and ’40s companies developed long acting types of insulin enabling patients to inject it less frequently, and in the ’70s and ’80s they improved the purity of insulins extracted from cows and pigs. Over the past 20 years companies have moved away from animal insulins to producing human insulins by using recombinant technology.
“Incremental innovation has repeatedly precluded the formation of a generic insulin industry in North America when earlier
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patents expired,” explained the authors. They acknowledged that these improvements were probably worth the added price for many patients but also noted, “What’s surprising is that the trailing edge of old insulin products did not generate a market for generic competition but rather became a set of obsolete products that were promptly removed from the US market.”
Greene and Riggs’s analysis found that generic drug companies did not consider it worthwhile to invest in manufacturing processes to produce older versions of insulin that people considered obsolete, when it was simpler to make small molecule drugs that had gone off patent. However, they considered that the latest generation of synthetic insulins and the potential to manufacture biosimilar insulins “may promise more competitive pricing.” But they warned that these may not be as cheap as typical generic medicines. “The case of insulin demonstrates that the generics market is like other markets—not an automatic phase in the life cycle of a drug,” they concluded. “Americans are paying a steep price for the continued rejuvenation of this oldest of modern medicines.” 1
Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med 2015; doi:10.1056/NEJMms1411398.
Cite this as: BMJ 2015;350:h1535 © BMJ Publishing Group Ltd 2015
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BMJ 2015;350:h1535 doi: 10.1136/bmj.h1535 (Published 20 March 2015)
Page 2 of 2
NEWS
Figure
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Subscribe: http://www.bmj.com/subscribe
Page 1 of 2
News
NEWS Insulin has never become a cheap generic drug in the US because of companies’ small changes to “evergreen” the patent Susan Mayor London
Drug companies have made incremental improvements to insulin that have kept it as a patented medicine in the United States for more than 90 years, shows a study tracing the drug’s history.
“The history of insulin highlights the limits of generic competition as a public health framework,” said the study authors, Jeremy Greene and Kevin Riggs, of Johns Hopkins University School of Medicine in Baltimore, USA, writing in the New England Journal of Medicine.[1] They warned, “Nearly a century after its discovery, there is still no inexpensive supply of insulin for people living with diabetes in North America.” To investigate why insulin is still not available as a low priced generic drug, Greene and Riggs traced its development over the past 100 years and found that drug companies have made incremental improvements that have extended their patents.
Insulin was discovered by a team at the University of Toronto, Canada, in 1921. In 1923 the university, which held the first patent for insulin, gave drug companies the right to manufacture it and to patent any improvements. During the 1930s and ’40s companies developed long acting types of insulin enabling patients to inject it less frequently, and in the ’70s and ’80s they improved the purity of insulins extracted from cows and pigs. Over the past 20 years companies have moved away from animal insulins to producing human insulins by using recombinant technology.
“Incremental innovation has repeatedly precluded the formation of a generic insulin industry in North America when earlier
For personal use only: See rights and reprints http://www.bmj.com/permissions
patents expired,” explained the authors. They acknowledged that these improvements were probably worth the added price for many patients but also noted, “What’s surprising is that the trailing edge of old insulin products did not generate a market for generic competition but rather became a set of obsolete products that were promptly removed from the US market.”
Greene and Riggs’s analysis found that generic drug companies did not consider it worthwhile to invest in manufacturing processes to produce older versions of insulin that people considered obsolete, when it was simpler to make small molecule drugs that had gone off patent. However, they considered that the latest generation of synthetic insulins and the potential to manufacture biosimilar insulins “may promise more competitive pricing.” But they warned that these may not be as cheap as typical generic medicines. “The case of insulin demonstrates that the generics market is like other markets—not an automatic phase in the life cycle of a drug,” they concluded. “Americans are paying a steep price for the continued rejuvenation of this oldest of modern medicines.” 1
Greene JA, Riggs KR. Why is there no generic insulin? Historical origins of a modern problem. N Engl J Med 2015; doi:10.1056/NEJMms1411398.
Cite this as: BMJ 2015;350:h1535 © BMJ Publishing Group Ltd 2015
Subscribe: http://www.bmj.com/subscribe
BMJ 2015;350:h1535 doi: 10.1136/bmj.h1535 (Published 20 March 2015)
Page 2 of 2
NEWS
Figure
For personal use only: See rights and reprints http://www.bmj.com/permissions
Subscribe: http://www.bmj.com/subscribe
