Given FDA regulation of biosimilars, it is practically impossible that low-cost generic insulin will ever be approved for US patients. The FDA treats biosimilars and chemical compounds differently and requires costly clinical trials. For a generic insulin, these costly clinical trials would result in pricing for any newly approved insulin that is very close to current insulin prices. See Trends in Biotechnology
FDA regulation does a good job of ensuring safe high volume commercial production of drugs. For insulin, this regulation ignores the public health damage of insulin prices that are not affordable for many and results in insulin rationing and cumulative damage from high BG that shortens people’s lifespans.
The growing availability of micro bio-production tools and knowledge such as MIT spinoff Amino Labs — https://amino.bio/, and the micro bio-production crowdfunding effort at Colorado State University promises that small-scale insulin production for under $10,000 will be a reality in the future.
“While Amino Labs is an education company that strives to make learning biomanufacturing and genetic engineering safe and accessible to all, we hope our technology inspires a transition towards domestication of biotechnology and therefore access to important medicine like insulin.” — Julie Legault, CEO, and co-Founder of Amino Labs.
The Open Insulin Project is seeking to develop an open protocol for insulin production.
“The Open Insulin project is working to develop a production system that will be under the democratic control of patients and is looking to the rich history of precedents in cooperative business organizations in medicine and other areas to guide these efforts. As someone with Type 1 diabetes, I have regularly been frustrated by the lack of consideration of my best interests in the products offered by pharmaceutical and medical device manufacturers. The best way to ensure that patient interests are well served is for us to be directly in charge of organizing our own care. The successes of DIY projects such as OpenAPS and Loop, which have developed systems for closed-loop control of blood glucose which far exceed in sophistication and effectiveness those offered by corporate medical device manufacturers, make this clear.” — Anthony Di Franco, Founder of Open Insulin Project
DIY insulin production is a regulatory blind spot for the FDA, There is currently no structure for regulating drugs that are not produced commercially.
This presents the FDA with a dilemma.
The FDA can revise how biosimilars are regulated to enable the introduction of low-cost generic insulin or they could lose control of the insulin marketplace. Patient co-ops making insulin for their own use would seem a natural and good outcome for many. However, if insulin prices remain high we may see a full-fledged underground supply system develop, just like has occurred for HIV which can also be treated with biologic drugs.
See CBS New York report — Illegal Insulin: Desperate Diabetes Patients Turn To Black Market For Affordable Drugs
The FDA exists to promote and protect the interests of patients. While the FDA is probably not happy with high insulin prices, it currently seems unable to guide the insulin market toward an accessible future.
More background on visions for small-scale production of biologics at / near point-of-care: