[RcouF1uZ4gsC]

>. For a generic insulin to get FDA approval it needs bioequivalence which is a lot like running the original safety and effect studies over again

That is incorrect. A bioequivalence study is much simpler and cheaper than the original safety and efficacy studies.

You do not need to prove that safety and efficacy of the drug, only that you are delivering the equivalent of the originally studied drug at the same doses.

https://en.wikipedia.org/wiki/Bioequivalence

[peyton]

No, the submission packages for anything chronically administered (like insulin follow-on) are way more comprehensive.

[projektfu]

Thank you. Insulin, being a biological, can't prove equivalence through just equivalent pharmacokinetics and contents.