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.).
