Could you give an example of what makes complex biologics difficult, is it the actual process or just the fact that IP is not shared easily and the hurdles to get licensing in place.
Because they're produced by biological processes (grow cells that produce the protein and purify it), you don't really have atom level control and replicability of the end product - there's a lot of variability. So, the exact process that it's produced with is regulated and tracked, and there will be IP over that process as well. You can see the impacts of that in how much harder biosimilars are to develop than generics
> for biologics, "the product is the process."
[0]: https://archive.bio.org/articles/how-do-drugs-and-biologics-...