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Re:Biohackers take aim at big pharma’s stranglehold on insulin by shkkmo on Tuesday June 29, 2021 @12:02PM (#27677828)
I don't know the exact details and I could be wrong, but my understanding is:

There is IP around the production process (specifically the genetic strain of e-coli). Because the production process is biological, generics produced with a different process are not automatically approved by the FDA and have to undergo an expensive approval process. Thus the goal here is to devolop a process with open IP and get that process approved.

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