By Chloe Teng
The turning point of humanity against the chronic disease of diabetes has long been hailed to be the spring of 1921. When Frederick G. Banting, along with the help of Charles Best and J.B. Collip, utilised extracts from the pancreas to decrease hyperglycaemia and glycosuria in diabetic dog models, insulin was discovered (Rosenfeld, 2002). In type 1 diabetes, the body’s immune system attacks beta cells in the pancreas, leading to an inability to synthesise insulin. In contrast, type 2 diabetes is a result of insulin resistance, whereby blood glucose levels continue to rise despite increased release of insulin as compensation. As such, insulin is often prescribed to type 2 diabetes individuals along with changes in physical activities and diet yet is vital as a treatment for type 1 diabetes patients. Approximately 400,000 people in the UK with type 1 diabetes rely on insulin treatments, and the number of type 1 diabetes cases are rising at roughly 4 percent every year (JDRF, 2018).
Understanding the importance of public accessibility towards their discovery, Banting and his team sold the patent for insulin at the cost of $1. Today, the global landscape of insulin sales would surely be unrecognisable to those before. Immense differences in insulin accessibility exist within various populations. For the 400,000 and growing type 1 diabetes patients in the UK, insulin prescriptions are freely provided by the NHS. However, in the United States, insulin retails at around $300 a vial, of which type 1 diabetes patients require two to three each month. At worst, it seems that these individuals will have to fork up $900, which is nearly £700, as a monthly subscription fee to stay alive (Diabetes Digital Media, 2019). This inequality is the result of many factors ranging from USA laws permitting pharmaceutical manufacturers to decide on and increase their own prices, to a lack of competition in the market. In particular, one of the driving forces in this price crisis is the lack of generic insulin availability.
Generics drugs are a much less foreign concept than what they initially may sound like. These are the same chemical substances as the drugs created by original patents, made with the same approved methods, and which work with the same efficacy as a treatment. After a certain time from which a manufacturer procures rights to produce a drug, other manufacturers are allowed to synthesise the same drug as well. For example, the generic Ibuprofen, a widely used over-the-counter anti-inflammatory drug, is simply the active drug of the original Nurofen® (Pharmacy-Xpress, 2020).
By definition, generic insulin cannot be produced since insulin is a biological product instead of a chemically synthesised molecule. Instead, when generic insulin is likened to the generic versions of branded drugs, it is referring to biosimilar insulin. Biosimilar insulins are produced using similar, but not identical, methods of production compared to the original patents. The process is comparatively more complex as biopharmaceuticals require extraction from living cells. Thus, biosimilars differ slightly in aspects such as molecular characteristics and clinical profiles. Due to this inability to simply duplicate insulin, the production costs saved using biosimilar insulin is about 15% of the original, in comparison to the usual 90% discount associated with generic drugs. (Greener, 2019) The higher cost, along with the time required to push the drug through all approval stages, ultimately disincentivises the emergence of new biosimilar insulin.
At present, 96% of the global insulin market is controlled by just three companies – Eli Lily, Novo Nordisk, and Sanofi. (Kwong, 2020) This growing dominance has discouraged competition, even resulting in monopolies of insulin supply in certain countries. However, even if companies rise above these challenges and successfully synthesise biosimilar insulin, other barriers remain. Firstly, a lack of clinical evidence and studies currently exist for comparing biosimilar insulin to brand-name insulin. Clinicians and diabetes patients alike are more likely to switch over to biosimilar insulins if important parameters can be proven to be at an identical quality to originators. One study evaluating 11 clinical trials points to biosimilar insulin being a valid alternative option, with pharmacokinetic, pharmacodynamic, efficacy, safety, and immunogenicity outcomes comparable to branded insulin (Tieu et al., 2018). However, more research is clearly required.
Besides that, there is the hidden cost in switching the delivery techniques and devices of insulin for diabetes patients. Delivery devices of biosimilar insulins may differ from original insulin. Basaglar, the biosimilar of Sanofi’s Lantus or insulin glargine, comes in cartridges that are not compatible with reusable Lantus pens. Although this does not contribute largely to the price of switching to biosimilars, it is vital to ensure that proper training should be provided for patients to avoid inadequate insulin dose administration when using new devices.
Finally, a major contributor to the accessibility issue of insulin includes the various strategies employed by current insulin market giants to deter their competitors. “Pay-for-delay” agreements are sometimes made between biosimilar manufacturers and companies holding the original patents. Biosimilar companies receive a payment from the patent-holders and in turn, agree to refrain from entering the market for a period of time. Otherwise, companies may also attempt to push competitors out of the market by legal action, wasting both time and legal fees that only result in a loss for diabetes patients. Furthermore, there have always been concerns regarding pharmaceutical companies lobbying political representatives through donations, thus creating pressure to put the issue of insulin price gouging on mute.
In 2019, the World Health Organisation recognised this complex issue and announced plans to tackle the rising costs of insulin, with a focus on encouraging biosimilar insulin production. With concentrated efforts, readily available and affordable biosimilar insulins are hoped by many to be the new turning point for diabetes treatments, just as the original insulin was long ago. It is, however, difficult not to reflect on how this insulin accessibility gap has taken shape over the years. It is not through a lack of advancing research, or a change in the way the disease afflicts individuals, that diabetes patients have had to face the difficulty of procuring this life-saving drug. Simply put, it is because of the greed of corporations that view the lives of diabetes patients as a means of profit. This, coupled with the failure of regulatory sectors to control the situation either through direct or indirect participation in this system, has spiralled into an insulin price crisis that has caused unnecessary loss of lives. A crisis purely human-bred, characterised by corruption, that one can only hope will end very, very soon.
References:
L Rosenfeld. 2002. Insulin: Discovery and Controversy. Clinical Chemistry, Vol 48, Issue 12, 2270-2288. doi.org/10.1093/clinchem/48.12.2270.
Juvenile Diabetes Research Foundation. 2018. Type 1 diabetes facts and figures. Available from: https://jdrf.org.uk/information-support/about-type-1-diabetes/facts-and-figures/ [3rd October 2020]
Diabetes Digital Media. 2019. Generic insulin availability could tackle soaring insulin costs. Available from: https://www.diabetes.co.uk/news/2019/Nov/generic-insulin-availability-could-tackle-soaring-insulin-costs.html [3rd October 2020]
Pharmacy-Xpress. 2020. Generic and Brand Names. Available from: http://www.pharmacy-xpress.co.uk/manuals/training-handbook/5-generic-and-brand-names#:~:text=However%2C%20generic%20medicines%20contain%20the,that%20first%20manufactured%20the%20drug. [2nd October 2020]
M Greener. 2019. Why isn’t the NHS making the most of biosimilar insulin? Available from: https://www.prescriber.co.uk/article/why-isnt-the-nhs-making-the-most-of-biosimilar-insulin/ [3rd October 2020]
E Kwong. 2020. The WHO knows insulin is too expensive. How it plans to drive down the price. Available from: https://www.npr.org/sections/goatsandsoda/2020/02/17/803762187/the-who-knows-insulin-is-too-expensive-how-it-plans-to-drive-down-the-price?t=1601756387997 [3rd October 2020]
C Tieu et al. 2018. Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review. PLoS One, Vol 13, Issue 4. 10.1371/journal.pone.0195012.
Imperial Bioscience Review 