The upfront costs of building out an insulin production facility and getting it FDA approved are quite high. Especially because insulin and insulin-analogs are

The upfront costs of building out an insulin production facility and getting it FDA approved are quite high. Especially because insulin and insulin-analogs are large molecules that are hard to prove are biologically equivalent to their patented versions. Which is made even more difficult by a large number of patents surrounding the manufacturing process the brand name company uses to produce it.