As we informed investors know, iPPS is exceedingly difficult to manufacture.
It has taken Bene not years but decades to refine the process to the exacting standards. Even if someone else could eventually crack the code, they would need such specialised in house developed machinery to not only replicate the process but to scale it.
Bene have spent ages on getting the product just right so that it is not only stable at room temperature but it has a decent commercial shelf life.
They have also spent a large amt of time trialing it out in various fit and finish containers/vials/injectables.
One of the biggest proofs of this isn't the sprawling factory full of these self developed mechanics...its not the random audits that the FDA conducts on a twice yearly basis....its not even the fact that the molecule itself has 40 sub units (moieties) ...also it's not even about the exact signature you need to have via gas chromatography and mass spectrometry...its the FDA saying themselves (Pre IND meeting with PAR) that its a very small chance of having a biosimilar AND its the fact that even giants like J&J gave up and just formed a partnership via Jansen with Bene to supply Elmiron.
Below from Baker and Young
Yeah I'm not saying no one will ever come up with a similar...but it will be 1) ages 2) it will be very onerous and expensive to get it exact with batch to batch consistency and to scale it. Bene are ISO 9000 certified. (One transaction in 6 million error rate).
My thoughts
ps: Don't believe me in terms of complexity? Read reference 1) in full:
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