yes apologies glargine was approved in 2000. And I agree it does take a while for doctors to switch. Something interesting that I have recently learned is that it may even be hard to find clinical trial participants because doctors will be hesitant to take patients who have good reactions to their current insulin off of that insulin to be a part of a clinical trial.
I will also say that Pharmacy Benefit Managers (PBMs) also have a lot of power when it comes to influencing doctors to begin prescribing new drugs.
While I don't know the answer to this in-depth I can share some bullet points and of course it depends on what country you are talking about. On top of that it is important to note that there are insulin shortages in various countries.
- one payer healthcare systems
- non-convoluted distribution systems
- depending where cheaper workforce/cheaper to make the insulin
- less stringent regulatory processes
- stronger lobbying groups in the US
I would like to point out that these fancy insulins have been around since 1996. I do agree that there is cheaper insulin available, but as others mentioned there is a significant change in quality. But I agree with you that the conversation should be affordable high quality insulin.
Another piece of the insulin ad drug saga that I haven't seen many people discuss here is the distribution of drugs. The distribution from manufacturers to patients is incredibly inefficent with a variety of middle organizations increasing the cost associated with distributing the insulin and those costs are pushed down onto patients. Our website has a simplified graph showing the current model vs what we plan on doing: https://projectinsulin.org/why-insulin/
This is a great question. Simply it is a lot cheaper to make drugs in China + India. The APIs cost less, and the workforce is cheaper. With regards to regulations I don't want to generalize but it has been well documented that it is hard for the FDA to regulate drugs being produced outside of the United States.
Hi as some of the others have already mentioned Lantus is off patent. My organization is focused on insulin glargine but there are generic versions of insulin lispro and aspart. Which is the generic/biosimilar version of humalog/novolog. We decided to stick with glargine first and transition to the other versions as we progress.
Unfortunately, this is true, and a lot of people struggle to manage their diabetes after switching to the Walmart brand. The stories I have heard generally occur to young adults who have to transition out of their parents' insurance plans.
The insulin that California would be getting from Civica Rx, at least, would be analog insulins. They are partnering together until California can make its own insulin. The biosimilars made by Mylan (Semglee) and Eli Lily (Basaglar) are both analog biosimilars, specifically biosimilar insulin glargine.
Hi Rayiner, you are spot on with your analysis. My name is Eric, and my non-profit, Project Insulin, is tackling this problem head-on as well. We are developing a biosimilar insulin and will distribute it directly to patients at cost. The drug development process is still expensive but much cheaper because of the Biologics Act that was passed in 2020. When going through the FDA approval process, biosimilar insulin makers don't have to do phase 2 trials, and their phase 1 & phase 3 are focused on interchangeability with the reference product rather than proving that insulin is a way to lower high blood sugars.
Another obstacle, as you pointed out, is that there are few manufacturers who produce synthetic insulins. From what I've learned in my discussions with manufacturers is that many are transitioning their facilities to a focus on mRNA drug manufacturing. Therefore there is a limited set of manufacturers who don't make insulin but have the equipment/facilities for it (in the U.S.).
I will also say that Pharmacy Benefit Managers (PBMs) also have a lot of power when it comes to influencing doctors to begin prescribing new drugs.