"Technically, there will never be generic insulin because it’s biologically based rather than chemical. Instead, there are bio-similars, which are products that are equivalent in function but they’re not 100 percent identical to the insulin they are replicating because the biological matter is very complex. Copying an existing chemical drug is straightforward. But for bio-similars, it is very difficult to point to a “generic” copy on insulin and prove that it is the same.
Even though the most recent insulin patents have been expiring since 2014, it is not easy for a fourth party to enter the market as their “copy” of the existing insulin would still be subject to a strict FDA review process to prove that their dosages would have the same effect on users that they receive from the existing insulin."
https://fee.org/articles/why-we-don-t-have-generic-insulin/?utm_source=zapier&utm
Even though the most recent insulin patents have been expiring since 2014, it is not easy for a fourth party to enter the market as their “copy” of the existing insulin would still be subject to a strict FDA review process to prove that their dosages would have the same effect on users that they receive from the existing insulin."
https://fee.org/articles/why-we-don-t-have-generic-insulin/?utm_source=zapier&utm