Why does insulin generic drugs not exist?
"Pharmaceutical companies that manufacture and sell out-of-patent medicines are manufactured and sold by other pharmaceutical companiesGeneric drug (generic drug)"Because it is the same ingredient as the original drug and the price is cheap, it is a bless present for those who regularly take medicine. However, it is used for treatment of diabetesInsulinAlthough generic medicines do not exist yet despite about 90 years passed since obtaining the patent. The reason is summarized by American magazine Pacific Standard.
Where's the Generic Insulin? - Pacific Standard
There are a total of 25.8 million people with diabetes in the United States with a total of 25.8 million people with type I diabetes and type II diabetes, and 6.7 million people, or about 25% of patients, use insulin to treat diabetes. Diabetes is a disease that risks life unless proper treatment is done, but if it is not covered by insurance, insulin administration will cost $ 120 to $ 140 a month (about 14,000 yen to 17,000 yen).
Site summarizing diabetes informationInsulin NationIn 2014Interview with diabetic patientsAs a result, it seems that one patient said that he gave up the doctor 's visit and the treatment of the teeth to make up for the insulin cost. Another patient reveals that insulin is cheaply sold at a pharmacy, buys it a little more, and reveals that it is also divided into families and relatives suffering from diabetes, and the problem of expensive insulin It turned out.
When a pharmaceutical patent expires, other pharmaceutical companies have the same ingredients and effectsGeneric drugsIt is possible to manufacture. Generic drugs are sold less cheaply than starting drugs because they do not cost new drug discovery and development. As insulin 's patent was first registered in 1923 and about 90 years have elapsed, even if an inexpensive generic drug has already appeared, it should not be surprising. However, there are reality that later generic pharmaceutical companies are not positive for insulin generic medicine manufacture due to "repeated patent renewal by pharmaceutical company" and "difficulty in duplication of medicine".
From the patent registration in 1923, by making detailed improvements such as increasing the efficacy of medicines, keeping the effect lasting for a long time, making tablets with higher purity, the pharmaceutical companies can apply patents of insulin I am continuing the right. Also, since insulin has a more complex structure than other drugs, replication is difficult,FDA (US Food and Drug Administration)Also imposes stricter standards for insulin than other drugs. Furthermore, as the FDA's standards are changed every time the patent renews, it is said that generic drug development of insulin can not produce results commensurate with effort. For these reasons, pharmaceutical companies holding patents for insulin continue to sell insulin at high prices forever.
Currently, an American generic drug manufacturing companyBoehringer IngelheimIs a generic drug for insulin against FDA "Basaglar"ofApplying for sale permissionHowever, Pacific Standard is analyzing that generic drugs are likely to take 10 years at least as long as 50 years at the earliest before it appears in the market.
in Science, Posted by darkhorse_log